# Anhui Province, Lu'an City Hongyuan Food Co., Ltd. · 16-120 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Anhui Province, Lu'an City Hongyuan Food Co., Ltd., import alert is 16-120; country is CHINA; import alert name is "Detention Without Physical Examination of ***Fish and Fishery*** Products from Foreign Processors (Mfrs.) Not in Compliance with Seafood HACCP ***Regulation***"; product is frozen boiled whole shrimp | frozen, cooked, vacuum-packaged crayfish | frozen boiled whole shrimp | frozen, cooked, vacuum-packaged crayfish; product code is 16 J - N 05 Shrimp & Prawns, Heat Treated | 16 J V N 02 Crayfish (Crawfish), Fresh Water, Vacuum or Modified Atmosphere Packaging, Heat Treated | 16 X - N 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products, Heat Treated | 16 X V N 20 Crayfish, Aquaculture Harvested Fishery/Seafood Products, Vacuum or Modified Atmosphere Packaging, Heat Treated; date published is 09/29/2026; address is Ping Qiao Hi-Tech Industrial Park , No. 4 Yongtai Rd; Yuan District , Liuan, Anhui CHINA, verified against its source on 2026-09-30.

- **Firm:** Anhui Province, Lu'an City Hongyuan Food Co., Ltd. _(verified: appears in the quote below)_
- **Import alert:** 16-120
- **Import alert name:** "Detention Without Physical Examination of ***Fish and Fishery*** Products from Foreign Processors (Mfrs.) Not in Compliance with Seafood HACCP ***Regulation***"
- **Country:** CHINA _(verified: appears in the quote below)_
- **Address:** Ping Qiao Hi-Tech Industrial Park , No. 4 Yongtai Rd; Yuan District , Liuan, Anhui CHINA _(verified: appears in the quote below)_
- **Date published:** 09/29/2026 _(verified: appears in the quote below)_
- **Product code:** 16 J - N 05 Shrimp & Prawns, Heat Treated | 16 J V N 02 Crayfish (Crawfish), Fresh Water, Vacuum or Modified Atmosphere Packaging, Heat Treated | 16 X - N 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products, Heat Treated | 16 X V N 20 Crayfish, Aquaculture Harvested Fishery/Seafood Products, Vacuum or Modified Atmosphere Packaging, Heat Treated _(verified: each item appears in its own passage below)_
- **Product:** frozen boiled whole shrimp | frozen, cooked, vacuum-packaged crayfish | frozen boiled whole shrimp | frozen, cooked, vacuum-packaged crayfish _(verified: each item appears in its own passage below)_
- **FDA notes:** FDA inspection of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). Based on FDA’s inspectional findings, the FDA determined that the firm’s frozen, cooked, vacuum-packaged processed in the facility appear to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Identified violations include: 21 CFR 123.6(c)(1), The firm’s HACCP plan does not list Clostridium botulinum toxin as a food safety hazard reasonably likely to occur, and 123.6(c)(7), Monitoring records do not contain actual values and observations obtained during monitoring, and 21 CFR 123.11(b) - failure monitor sanitation conditions and practices with sufficient frequency. | FDA inspection of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). Based on FDA’s inspectional findings, the FDA determined that the firm’s frozen, cooked, vacuum-packaged processed in the facility appear to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Identified violations include: 21 CFR 123.6(c)(1), The firm’s HACCP plan does not list Clostridium botulinum toxin as a food safety hazard reasonably likely to occur, and 123.6(c)(7), Monitoring records do not contain actual values and observations obtained during monitoring, and 21 CFR 123.11(b) - failure monitor sanitation conditions and practices with sufficient frequency. | FDA inspection of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). Based on FDA’s inspectional findings, the FDA determined that the firm’s frozen, cooked, vacuum-packaged processed in the facility appear to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Identified violations include: 21 CFR 123.6(c)(1), The firm’s HACCP plan does not list Clostridium botulinum toxin as a food safety hazard reasonably likely to occur, and 123.6(c)(7), Monitoring records do not contain actual values and observations obtained during monitoring, and 21 CFR 123.11(b) - failure monitor sanitation conditions and practices with sufficient frequency. | FDA inspection of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). Based on FDA’s inspectional findings, the FDA determined that the firm’s frozen, cooked, vacuum-packaged processed in the facility appear to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Identified violations include: 21 CFR 123.6(c)(1), The firm’s HACCP plan does not list Clostridium botulinum toxin as a food safety hazard reasonably likely to occur, and 123.6(c)(7), Monitoring records do not contain actual values and observations obtained during monitoring, and 21 CFR 123.11(b) - failure monitor sanitation conditions and practices with sufficient frequency. _(verified: each item appears in its own passage below)_

## What the source says

> Anhui Province, Lu'an City Hongyuan Food Co., Ltd. Date Published : 09/29/2026 Ping Qiao Hi-Tech Industrial Park , No. 4 Yongtai Rd; Yuan District , Liuan, Anhui CHINA

## Where each value comes from

This source states these in separate places, so each value is shown with the passage that states it.

### Product code

> 16 J - N 05 Shrimp & Prawns, Heat Treated Date Published: 09/29/2026 Desc: frozen boiled whole shrimp Notes: FDA inspection of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). Based on FDA’s inspectional findings, the FDA determined that the firm’s frozen, cooked, vacuum-packaged processed in the facility appear to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Identified violations include: 21 CFR 123.6(c)(1), The firm’s HACCP plan does not list Clostridium botulinum toxin as a food safety hazard reasonably likely to occur, and 123.6(c)(7), Monitoring records do not contain actual values and observations obtained during monitoring, and 21 CFR 123.11(b) - failure monitor sanitation conditions and practices with sufficient frequency. 16 J V N 02 Crayfish (Crawfish), Fresh Water, Vacuum or Modified Atmosphere Packaging, Heat Treated Date Published: 09/29/2026 Desc: frozen, cooked, vacuum-packaged crayfish Notes: FDA inspection of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). Based on FDA’s inspectional findings, the FDA determined that the firm’s frozen, cooked, vacuum-packaged processed in the facility appear to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Identified violations include: 21 CFR 123.6(c)(1), The firm’s HACCP plan does not list Clostridium botulinum toxin as a food safety hazard reasonably likely to occur, and 123.6(c)(7), Monitoring records do not contain actual values and observations obtained during monitoring, and 21 CFR 123.11(b) - failure monitor sanitation conditions and practices with sufficient frequency. 16 X - N 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products, Heat Treated Date Published: 09/29/2026 Desc: frozen boiled whole shrimp Notes: FDA inspection of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). Based on FDA’s inspectional findings, the FDA determined that the firm’s frozen, cooked, vacuum-packaged processed in the facility appear to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Identified violations include: 21 CFR 123.6(c)(1), The firm’s HACCP plan does not list Clostridium botulinum toxin as a food safety hazard reasonably likely to occur, and 123.6(c)(7), Monitoring records do not contain actual values and observations obtained during monitoring, and 21 CFR 123.11(b) - failure monitor sanitation conditions and practices with sufficient frequency. 16 X V N 20 Crayfish, Aquaculture Harvested Fishery/Seafood Products, Vacuum or Modified Atmosphere Packaging, Heat Treated Date Published: 09/29/2026 Desc: frozen, cooked, vacuum-packaged crayfish Notes: FDA inspection of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). Based on FDA’s inspectional findings, the FDA determined that the firm’s frozen, cooked, vacuum-packaged processed in the facility appear to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Identified violations include: 21 CFR 123.6(c)(1), The firm’s HACCP plan does not list Clostridium botulinum toxin as a food safety hazard reasonably likely to occur, and 123.6(c)(7), Monitoring records do not contain actual values and observations obtained during monitoring, and 21 CFR 123.11(b) - failure monitor sanitation conditions and practices with sufficient frequency.

### Product

> 16 J - N 05 Shrimp & Prawns, Heat Treated Date Published: 09/29/2026 Desc: frozen boiled whole shrimp Notes: FDA inspection of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). Based on FDA’s inspectional findings, the FDA determined that the firm’s frozen, cooked, vacuum-packaged processed in the facility appear to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Identified violations include: 21 CFR 123.6(c)(1), The firm’s HACCP plan does not list Clostridium botulinum toxin as a food safety hazard reasonably likely to occur, and 123.6(c)(7), Monitoring records do not contain actual values and observations obtained during monitoring, and 21 CFR 123.11(b) - failure monitor sanitation conditions and practices with sufficient frequency. 16 J V N 02 Crayfish (Crawfish), Fresh Water, Vacuum or Modified Atmosphere Packaging, Heat Treated Date Published: 09/29/2026 Desc: frozen, cooked, vacuum-packaged crayfish Notes: FDA inspection of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). Based on FDA’s inspectional findings, the FDA determined that the firm’s frozen, cooked, vacuum-packaged processed in the facility appear to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Identified violations include: 21 CFR 123.6(c)(1), The firm’s HACCP plan does not list Clostridium botulinum toxin as a food safety hazard reasonably likely to occur, and 123.6(c)(7), Monitoring records do not contain actual values and observations obtained during monitoring, and 21 CFR 123.11(b) - failure monitor sanitation conditions and practices with sufficient frequency. 16 X - N 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products, Heat Treated Date Published: 09/29/2026 Desc: frozen boiled whole shrimp Notes: FDA inspection of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). Based on FDA’s inspectional findings, the FDA determined that the firm’s frozen, cooked, vacuum-packaged processed in the facility appear to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Identified violations include: 21 CFR 123.6(c)(1), The firm’s HACCP plan does not list Clostridium botulinum toxin as a food safety hazard reasonably likely to occur, and 123.6(c)(7), Monitoring records do not contain actual values and observations obtained during monitoring, and 21 CFR 123.11(b) - failure monitor sanitation conditions and practices with sufficient frequency. 16 X V N 20 Crayfish, Aquaculture Harvested Fishery/Seafood Products, Vacuum or Modified Atmosphere Packaging, Heat Treated Date Published: 09/29/2026 Desc: frozen, cooked, vacuum-packaged crayfish Notes: FDA inspection of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). Based on FDA’s inspectional findings, the FDA determined that the firm’s frozen, cooked, vacuum-packaged processed in the facility appear to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Identified violations include: 21 CFR 123.6(c)(1), The firm’s HACCP plan does not list Clostridium botulinum toxin as a food safety hazard reasonably likely to occur, and 123.6(c)(7), Monitoring records do not contain actual values and observations obtained during monitoring, and 21 CFR 123.11(b) - failure monitor sanitation conditions and practices with sufficient frequency.

### FDA notes

> 16 J - N 05 Shrimp & Prawns, Heat Treated Date Published: 09/29/2026 Desc: frozen boiled whole shrimp Notes: FDA inspection of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). Based on FDA’s inspectional findings, the FDA determined that the firm’s frozen, cooked, vacuum-packaged processed in the facility appear to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Identified violations include: 21 CFR 123.6(c)(1), The firm’s HACCP plan does not list Clostridium botulinum toxin as a food safety hazard reasonably likely to occur, and 123.6(c)(7), Monitoring records do not contain actual values and observations obtained during monitoring, and 21 CFR 123.11(b) - failure monitor sanitation conditions and practices with sufficient frequency. 16 J V N 02 Crayfish (Crawfish), Fresh Water, Vacuum or Modified Atmosphere Packaging, Heat Treated Date Published: 09/29/2026 Desc: frozen, cooked, vacuum-packaged crayfish Notes: FDA inspection of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). Based on FDA’s inspectional findings, the FDA determined that the firm’s frozen, cooked, vacuum-packaged processed in the facility appear to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Identified violations include: 21 CFR 123.6(c)(1), The firm’s HACCP plan does not list Clostridium botulinum toxin as a food safety hazard reasonably likely to occur, and 123.6(c)(7), Monitoring records do not contain actual values and observations obtained during monitoring, and 21 CFR 123.11(b) - failure monitor sanitation conditions and practices with sufficient frequency. 16 X - N 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products, Heat Treated Date Published: 09/29/2026 Desc: frozen boiled whole shrimp Notes: FDA inspection of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). Based on FDA’s inspectional findings, the FDA determined that the firm’s frozen, cooked, vacuum-packaged processed in the facility appear to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Identified violations include: 21 CFR 123.6(c)(1), The firm’s HACCP plan does not list Clostridium botulinum toxin as a food safety hazard reasonably likely to occur, and 123.6(c)(7), Monitoring records do not contain actual values and observations obtained during monitoring, and 21 CFR 123.11(b) - failure monitor sanitation conditions and practices with sufficient frequency. 16 X V N 20 Crayfish, Aquaculture Harvested Fishery/Seafood Products, Vacuum or Modified Atmosphere Packaging, Heat Treated Date Published: 09/29/2026 Desc: frozen, cooked, vacuum-packaged crayfish Notes: FDA inspection of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). Based on FDA’s inspectional findings, the FDA determined that the firm’s frozen, cooked, vacuum-packaged processed in the facility appear to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Identified violations include: 21 CFR 123.6(c)(1), The firm’s HACCP plan does not list Clostridium botulinum toxin as a food safety hazard reasonably likely to occur, and 123.6(c)(7), Monitoring records do not contain actual values and observations obtained during monitoring, and 21 CFR 123.11(b) - failure monitor sanitation conditions and practices with sufficient frequency.

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_25.html

Last verified: 2026-09-30. Review by: 2026-11-29.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).