The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.
Donggang Wanrui Food Co.,Ltd.
Donggang, Liaoning, China
The FDA conducted an inspection of Donggang Wanrui Food Co., Ltd. on Jan. 22, 2024, and found significant violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation. The firm failed to implement proper monitoring and recordkeeping procedures for raw frozen small octopus and raw frozen cut crab, leading to potential adulteration of these products. Additionally, the firm’s HACCP plans did not list major food allergens as hazards, nor did they properly monitor sanitation conditions.
Key Violations listed in a June 25 warning letter include:
- Inadequate monitoring and recordkeeping for receiving and production processes.
- Failure to identify allergens in HACCP plans.
- Fabrication of sanitation monitoring records.
The full warning letter can be viewed here.
Dalian Lingfa Food Co. Ltd.
Dalian, Liaoning, China
An inspection of Dalian Lingfa Food Co. Ltd. from Jan. 17 to 19, 2024, identified serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule). The firm failed to control the hazard of Clostridium botulinum in their seasoned bamboo shoots due to inadequate hazard analysis and monitoring of product temperatures during storage.
Key Violations listed in a June 3 warning letter include:
- Failure to consider Clostridium botulinum in hazard analysis.
- Inadequate temperature monitoring during storage.
- Lack of a revised hazard analysis and insufficient corrective actions.
The full warning letter can be viewed here.
Blue Caribbean Foods Inc.
Kingstown, Saint George, Grenada
Blue Caribbean Foods Inc. was inspected by the FDA on Nov. 13-14, 2023, revealing violations of the seafood HACCP regulation. The firm did not have adequate HACCP plans for controlling scombrotoxin (histamine) formation in fresh tuna. Additionally, the firm failed to implement proper monitoring and corrective actions at critical control points.
Key violations listed in an April 24 warning letter include:
- Inadequate critical control points for transportation and storage of tuna.
- Failure to monitor internal temperatures and histamine levels.
- Insufficient corrective actions for deviations in critical limits.
The full warning letter can be viewed here.
G.N.R. Group Co. LTD.
Bangkok, Thailand
The FDA’s inspection of G.N.R. Group Co., LTD. on Jan. 22-23, 2024, found significant deviations in their juice HACCP systems. The firm’s HACCP plan for frozen coconut juice did not include control measures that would consistently produce a 5-log reduction of Clostridium botulinum, a necessary safety measure for low-acid juice products.
Key violations listed in an April 17 warning letter include:
- Inadequate thermal processing controls for coconut juice.
- Lack of documentation to demonstrate the efficacy of the pasteurization process.
The full warning letter can be viewed here.
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