SANKOUFOODS CO.,LTD · 99-39 · JAPAN
For SANKOUFOODS CO.,LTD · 99-39 · JAPAN, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is JAPAN; product is Asari Clams Tsukudami | Clams with Garlic Tsukudani; product code is 16 E - - 02 Clams | 16 E - - 02 Clams; date published is 12/02/2016; address is Ma2204 , Noma; Shodoshima-Cho , Shozu-Gun, Kagawa JAPAN, verified against its source on 2026-09-16.
- Firm
- SANKOUFOODS CO.,LTD verified
- Import alert
- 99-39
- Import alert name
- Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
- Country
- JAPAN verified
- Address
- Ma2204 , Noma; Shodoshima-Cho , Shozu-Gun, Kagawa JAPAN verified
- Date published
- 12/02/2016 verified
- Product code
- 16 E - - 02 Clams | 16 E - - 02 Clams each item verified
- Product
- Asari Clams Tsukudami | Clams with Garlic Tsukudani each item verified
- FDA notes
- Articles are subject to refusal in that they appear to be misbranded under 403 (q) of the Act [21 U.S.C. 403(q)]. Nutrition facts label is not in proper format per 21 CFR 101.9; Serving size of 1 oz. (28g) is declared; however, the Referenced Amount Customarily Consumed (RACC) for this product is 55 grams (21 CFR 101.12 (b). Therefore, the serving size is incorrectly determined from the RACC; hence, all the nutrient information is incorrectly declared; Nutrition label does not appear to be provided in the foreign language per 21 CFR 101.9(d)(14); Serving size declarations do not appear to include a visual unit of measure per 21 CFR 101.9(b)(5)(vi); Labels do not indent Saturated fat, Trans fat, Dietary fiber, and Sugars per 21 CFR 101.9(c)(2)(i), 21 CFR 101.9(c)(2)(ii), 21 CFR 101.9(c)(6)(i), and 21 CFR 101.9(c)(6)(ii), respectively; Labels do not bold required values per 21 CFR 101.9(d)(1)(iv); Nutrition labels do not appear to be enclosed in a box using hairlines per 21 CFR 101.9(d)(1)(i); Articles are subject to refusal in that they appear to be misbranded under 403 (k) of the Act [21 U.S.C. 343(k)]. Product contains an artificial coloring, flavoring, or chemical preservative, Sorbic Acid K, which is not identified as a preservative per 21 CFR 101.22(j); Articles are subject to refusal in that they appear to be misbranded under 403 (f) of the Act [21 U.S.C.343(f)]; Labels contain information in two languages, but do not repeat the required information in both languages, per 21 CFR 101.15(c); Mandatory label information appears to be displayed on the bottom of the package, which must be placed either on the principal display panel (PDP) or the information panel per 21 CFR 101.3, 101.7 and 101.2; Ingredient declarations not do not appear to be in terms that are likely to be understood by ordinary individuals due to words that are incorrectly divided and continued on the following line, and misplaced commas; | Articles are subject to refusal in that they appear to be misbranded under 403 (q) of the Act [21 U.S.C. 403(q)]. Nutrition facts label is not in proper format per 21 CFR 101.9; Serving size of 1 oz. (28g) is declared; however, the Referenced Amount Customarily Consumed (RACC) for this product is 55 grams (21 CFR 101.12 (b). Therefore, the serving size is incorrectly determined from the RACC; hence, all the nutrient information is incorrectly declared; Nutrition label does not appear to be provided in the foreign language per 21 CFR 101.9(d)(14); Serving size declarations do not appear to include a visual unit of measure per 21 CFR 101.9(b)(5)(vi); Labels do not indent Saturated fat, Trans fat, Dietary fiber, and Sugars per 21 CFR 101.9(c) (2)(i), 21 CFR 101.9(c)(2)(ii), 21 CFR 101.9(c)(6)(i), and 21 CFR 101.9(c)(6) (ii), respectively; Labels do not bold required values per 21 CFR 101.9(d)(1) (iv); Nutrition labels do not appear to be enclosed in a box using hairlines per 21 CFR 101.9(d)(1)(i); Articles are subject to refusal in that they appear to be misbranded under 403 (k) of the Act [21 U.S.C. 343(k)]. Product contains an artificial coloring, flavoring, or chemical preservative, Sorbic Acid K, which is not identified as a preservative per 21 CFR 101.22(j); Articles are subject to refusal in that they appear to be misbranded under 403 (f) of the Act [21 U.S.C.343(f)]; Labels contain information in two languages, but do not repeat the required information in both languages, per 21 CFR 101.15(c); Mandatory label information appears to be displayed on the bottom of the package, which must be placed either on the principal display panel (PDP) or the information panel per 21 CFR 101.3, 101.7 and 101.2; Ingredient declarations not do not appear to be in terms that are likely to be understood by ordinary individuals due to words that are incorrectly divided and continued on the following line, and misplaced commas; each item verified
What the source says
SANKOUFOODS CO.,LTD Date Published : 12/02/2016 Ma2204 , Noma; Shodoshima-Cho , Shozu-Gun, Kagawa JAPAN 16 E - - 02 Clams Date Published: 12/02/2016 Desc: Asari Clams Tsukudami Notes: Articles are subject to refusal in that they appear to be misbranded under 403 (q) of the Act [21 U.S.C. 403(q)]. Nutrition facts label is not in proper format per 21 CFR 101.9; Serving size of 1 oz. (28g) is declared; however, the Referenced Amount Customarily Consumed (RACC) for this product is 55 grams (21 CFR 101.12 (b). Therefore, the serving size is incorrectly determined from the RACC; hence, all the nutrient information is incorrectly declared; Nutrition label does not appear to be provided in the foreign language per 21 CFR 101.9(d)(14); Serving size declarations do not appear to include a visual unit of measure per 21 CFR 101.9(b)(5)(vi); Labels do not indent Saturated fat, Trans fat, Dietary fiber, and Sugars per 21 CFR 101.9(c)(2)(i), 21 CFR 101.9(c)(2)(ii), 21 CFR 101.9(c)(6)(i), and 21 CFR 101.9(c)(6)(ii), respectively; Labels do not bold required values per 21 CFR 101.9(d)(1)(iv); Nutrition labels do not appear to be enclosed in a box using hairlines per 21 CFR 101.9(d)(1)(i); Articles are subject to refusal in that they appear to be misbranded under 403 (k) of the Act [21 U.S.C. 343(k)]. Product contains an artificial coloring, flavoring, or chemical preservative, Sorbic Acid K, which is not identified as a preservative per 21 CFR 101.22(j); Articles are subject to refusal in that they appear to be misbranded under 403 (f) of the Act [21 U.S.C.343(f)]; Labels contain information in two languages, but do not repeat the required information in both languages, per 21 CFR 101.15(c); Mandatory label information appears to be displayed on the bottom of the package, which must be placed either on the principal display panel (PDP) or the information panel per 21 CFR 101.3, 101.7 and 101.2; Ingredient declarations not do not appear to be in terms that are likely to be understood by ordinary individuals due to words that are incorrectly divided and continued on the following line, and misplaced commas; 16 E - - 02 Clams Date Published: 12/02/2016 Desc: Clams with Garlic Tsukudani Notes: Articles are subject to refusal in that they appear to be misbranded under 403 (q) of the Act [21 U.S.C. 403(q)]. Nutrition facts label is not in proper format per 21 CFR 101.9; Serving size of 1 oz. (28g) is declared; however, the Referenced Amount Customarily Consumed (RACC) for this product is 55 grams (21 CFR 101.12 (b). Therefore, the serving size is incorrectly determined from the RACC; hence, all the nutrient information is incorrectly declared; Nutrition label does not appear to be provided in the foreign language per 21 CFR 101.9(d)(14); Serving size declarations do not appear to include a visual unit of measure per 21 CFR 101.9(b)(5)(vi); Labels do not indent Saturated fat, Trans fat, Dietary fiber, and Sugars per 21 CFR 101.9(c) (2)(i), 21 CFR 101.9(c)(2)(ii), 21 CFR 101.9(c)(6)(i), and 21 CFR 101.9(c)(6) (ii), respectively; Labels do not bold required values per 21 CFR 101.9(d)(1) (iv); Nutrition labels do not appear to be enclosed in a box using hairlines per 21 CFR 101.9(d)(1)(i); Articles are subject to refusal in that they appear to be misbranded under 403 (k) of the Act [21 U.S.C. 343(k)]. Product contains an artificial coloring, flavoring, or chemical preservative, Sorbic Acid K, which is not identified as a preservative per 21 CFR 101.22(j); Articles are subject to refusal in that they appear to be misbranded under 403 (f) of the Act [21 U.S.C.343(f)]; Labels contain information in two languages, but do not repeat the required information in both languages, per 21 CFR 101.15(c); Mandatory label information appears to be displayed on the bottom of the package, which must be placed either on the principal display panel (PDP) or the information panel per 21 CFR 101.3, 101.7 and 101.2; Ingredient declarations not do not appear to be in terms that are likely to be understood by ordinary individuals due to words that are incorrectly divided and continued on the following line, and misplaced commas;
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1144.html
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