The Kuwaiti Danish Dairy Company KCSC · 99-37 · KUWAIT

For The Kuwaiti Danish Dairy Company KCSC · 99-37 · KUWAIT, import alert is 99-37; import alert name is "DETENTION WITHOUT PHYSICAL EXAMINATION OF LOW-ACID CANNED FOODS AND ACIDIFIED FOODS WITHOUT FILED SCHEDULED PROCESSES"; country is KUWAIT; product code is 02 - - - -- Whole Grains/Milled Grain Products/Starches | 03 - - - -- Bakery Products/Dough/Mixes/Icings | 04 - - - -- Macaroni/Noodle Products | 05 - - - -- Cereal Preparations/Breakfast Foods | 07 - - - -- Snack Food Items | 09 - - - -- Milk/Butter/Dried Milk Products | 12 - - - -- Cheese/Cheese Products | 13 - - - -- Ice Cream and related Products | 14 - - - -- Filled Milk/Imitation Milk Products | 15 - - - -- Eggs/Egg Products | 16 - - - -- Fishery/Seafood Products | 17 - - - -- Meats, Meat Products and Poultry | 18 - - - -- Vegetable Protein Products | 20 - - - -- Fruit/Fruit Products | 21 - - - -- Fruit/Fruit Products | 22 - - - -- Fruit/Fruit Products | 23 - - - -- Nuts/Edible Seeds | 24 - - - -- Vegetables/Vegetable Products | 25 - - - -- Vegetables/Vegetable Products | 26 - - - -- Vegetable Oils | 27 - - - -- Dressing/Condiments | 28 - - - -- Spices, Flavors And Salts | 29 - - - -- Drinks, Soft Drinks, and Waters | 30 - - - -- Beverage Bases/Concentrates/Nectars | 31 - - - -- Coffee/Tea | 32 - - - -- Alcoholic Beverages | 33 - - - -- Candy W/O Chocolate/Candy Specialties/Chewing Gums | 34 - - - -- Chocolate/Cocoa Products/Cocoa beans | 35 - - - -- Gelatin/Rennet/Pudding Mixes/Pie Fillings | 36 - - - -- Food Sweeteners/Nutritive syrups/honey/molasses | 37 - - - -- Multiple food dinners/Gravies/Sauces/Specialties | 38 - - - -- Soups | 39 - - - -- Prepared Salad Products | 40 A - - -- Baked Goods (Baby) | 40 B - - -- Cereal (Baby) | 40 D - - -- Veg (Baby) | 40 E - - -- Fruit/Juice/Drink (Baby) | 40 F - - -- Meat Prod/Comb Meat Dinner (Baby) | 40 G - - -- Poultry Prod/Comb Poultry Dinner (Baby) | 40 H - - -- High Meat Dinner/Cheese Food (Baby) | 40 I - - -- Fish-Seafood Prod (Baby) | 40 J - - -- Egg Prod (Baby) | 40 K - - -- Pudding/Custard (Baby) | 40 L - - -- Soups/Soup Mix (Baby) | 40 Q - - -- Pasta and Noodle Combination Dinners Without Meat | 40 X - - -- Market Basket Sampling | 40 Y - - -- Baby Food N.E.C. | 41 - - - -- Dietary Conv Food/Meal Replacements | 42 A - - -- Whole Edible Insects (adults and immature stages) | 42 B - - -- Milled Edible Insect Products | 42 C - - -- Edible Insect Bars | 42 D - - -- Edible Insect Bakery Products | 42 E - - -- Edible Insect Candy With Chocolate | 42 F - - -- Edible Insect Candy Without Chocolate | 42 G - - -- Edible Insect Capsules | 42 H - - -- Edible Insect Granola or Trail Mix | 42 I - - -- Edible Insect Jerky | 42 J - - -- Edible Insect Ice Cream and Related Products | 42 K - - -- Edible Insect Oils | 42 L - - -- Edible Insect Smoothies | 42 M - - -- Edible Insect Soups | 42 N - - -- Edible Insect Spreads And Pastes | 42 O - - -- Edible Insect Beverages | 42 P - - -- Edible Insect Protein: Simulated Meats and Tofu | 42 Q - - -- Edible Insect Salts and Spices | 42 R - - -- Edible Insect Products N.E.C. | 52 B - - 06 Corn Husks (Food Related) | 52 B - - 07 Snail Shells (Food Related) | 52 B - - 08 Sausage Casings, Artificial (Food Related) | 52 B - - 12 Non-Edible Bird's Nest | 52 D - - -- Live Animals; date published is 06/10/2025; address is Sabhan Industiral Area, Block 1, Plot 157, Street 104 , Sabhan, KUWAIT, verified against its source on 2026-09-16.

What the source says

The Kuwaiti Danish Dairy Company KCSC Date Published : 06/10/2025 Sabhan Industiral Area, Block 1, Plot 157, Street 104 , Sabhan, KUWAIT 02 - - - -- Whole Grains/Milled Grain Products/Starches Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 03 - - - -- Bakery Products/Dough/Mixes/Icings Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 04 - - - -- Macaroni/Noodle Products Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 05 - - - -- Cereal Preparations/Breakfast Foods Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 07 - - - -- Snack Food Items Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 09 - - - -- Milk/Butter/Dried Milk Products Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 12 - - - -- Cheese/Cheese Products Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 13 - - - -- Ice Cream and related Products Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 14 - - - -- Filled Milk/Imitation Milk Products Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 15 - - - -- Eggs/Egg Products Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 16 - - - -- Fishery/Seafood Products Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 17 - - - -- Meats, Meat Products and Poultry Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 18 - - - -- Vegetable Protein Products Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 20 - - - -- Fruit/Fruit Products Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 21 - - - -- Fruit/Fruit Products Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 22 - - - -- Fruit/Fruit Products Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 23 - - - -- Nuts/Edible Seeds Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 24 - - - -- Vegetables/Vegetable Products Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 25 - - - -- Vegetables/Vegetable Products Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 26 - - - -- Vegetable Oils Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 27 - - - -- Dressing/Condiments Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 28 - - - -- Spices, Flavors And Salts Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 29 - - - -- Drinks, Soft Drinks, and Waters Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 30 - - - -- Beverage Bases/Concentrates/Nectars Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 31 - - - -- Coffee/Tea Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 32 - - - -- Alcoholic Beverages Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 33 - - - -- Candy W/O Chocolate/Candy Specialties/Chewing Gums Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 34 - - - -- Chocolate/Cocoa Products/Cocoa beans Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 35 - - - -- Gelatin/Rennet/Pudding Mixes/Pie Fillings Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 36 - - - -- Food Sweeteners/Nutritive syrups/honey/molasses Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 37 - - - -- Multiple food dinners/Gravies/Sauces/Specialties Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 38 - - - -- Soups Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 39 - - - -- Prepared Salad Products Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 40 A - - -- Baked Goods (Baby) Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 40 B - - -- Cereal (Baby) Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 40 D - - -- Veg (Baby) Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 40 E - - -- Fruit/Juice/Drink (Baby) Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 40 F - - -- Meat Prod/Comb Meat Dinner (Baby) Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 40 G - - -- Poultry Prod/Comb Poultry Dinner (Baby) Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 40 H - - -- High Meat Dinner/Cheese Food (Baby) Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 40 I - - -- Fish-Seafood Prod (Baby) Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 40 J - - -- Egg Prod (Baby) Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 40 K - - -- Pudding/Custard (Baby) Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 40 L - - -- Soups/Soup Mix (Baby) Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 40 Q - - -- Pasta and Noodle Combination Dinners Without Meat Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 40 X - - -- Market Basket Sampling Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 40 Y - - -- Baby Food N.E.C. Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 41 - - - -- Dietary Conv Food/Meal Replacements Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 42 A - - -- Whole Edible Insects (adults and immature stages) Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 42 B - - -- Milled Edible Insect Products Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 42 C - - -- Edible Insect Bars Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 42 D - - -- Edible Insect Bakery Products Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 42 E - - -- Edible Insect Candy With Chocolate Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 42 F - - -- Edible Insect Candy Without Chocolate Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 42 G - - -- Edible Insect Capsules Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 42 H - - -- Edible Insect Granola or Trail Mix Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 42 I - - -- Edible Insect Jerky Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 42 J - - -- Edible Insect Ice Cream and Related Products Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 42 K - - -- Edible Insect Oils Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 42 L - - -- Edible Insect Smoothies Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 42 M - - -- Edible Insect Soups Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 42 N - - -- Edible Insect Spreads And Pastes Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 42 O - - -- Edible Insect Beverages Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 42 P - - -- Edible Insect Protein: Simulated Meats and Tofu Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 42 Q - - -- Edible Insect Salts and Spices Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 42 R - - -- Edible Insect Products N.E.C. Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 52 B - - 06 Corn Husks (Food Related) Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 52 B - - 07 Snail Shells (Food Related) Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 52 B - - 08 Sausage Casings, Artificial (Food Related) Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 52 B - - 12 Non-Edible Bird's Nest Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs). 52 D - - -- Live Animals Date Published: 06/10/2025 Notes: All low-acid canned foods products FDA conducted an inspection of this aseptically filled and packaged low-acid food manufacturing facility finding serious deviations of the of the Emergency Permit Control regulation (21 CFR Part 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). Based on FDA’s inspectional findings and the firm’s inadequate response to findings, all low-acid canned food products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 108.35(c)(2) – the firm has not filed scheduled process. Labeling an LACF product as “Keep refrigerated” is not an adequate control measure, as refrigeration may slow microbial growth but does not eliminate the risk of C. botulinum as spores can survive at low temperatures and can reactivate if the product is subjected to temperature abuse during distribution or storage. 21 CFR 113.83 – scheduled processes for low-acid foods were not established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers. Critical factors affecting the scheduled process must be specified in the scheduled process. All critical factors must be monitored in accordance with 21 CFR 113.100(a). Furthermore, heat sterilization processes must be established based upon acceptable scientific methods, (e.g., heat penetration data and inoculated packs).

— accessdata.fda.gov, retrieved 2026-09-15

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• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1131.html

Last verified against source: 2026-09-16. Due for re-check by 2026-11-15. This page as Markdown · OKF bundle · full dataset as JSON.