FDA WARNING_LETTER - Donggang Wanrui Food Co., Ltd. - January 22, 2024

The FDA inspected Donggang Wanrui Food Co., Ltd. in China on January 22, 2024, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's raw frozen small octopus and raw frozen cut crab products are deemed adulterated.

Key violations include: 1. **Failure to implement monitoring and recordkeeping procedures (21 CFR 123.6(b)):** The firm did not follow monitoring for the Acquisition of (b)(4) Step critical control point (CCP1), failing to maintain receiving records (fishing tags, licenses) for raw octopus and crab in 2023. Production records for 2022 batches were created only after the FDA pre-announced the inspection. 2. **Inadequate hazard analysis and HACCP plan (21 CFR 123.6(a) and (c)(1)):** The HACCP plans for raw frozen small octopus and raw frozen cut crab did not list allergens (crab, monkfish) as a food safety hazard, failing to ensure proper labeling under the Food Allergen Labeling and Consumer Protection Act of 2004. 3. **Fabricated sanitation monitoring records (21 CFR 123.11I, 123.9(a)(4)):** Daily sanitation monitoring records from March