FDA warns Vietnamese tuna processor over histamine safety violations

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.

Golden Shrimp Seafood Joint Stock Company

Vietnam

On May 13, 2024, the U.S. Food and Drug Administration (FDA) issued a warning letter to Golden Shrimp Seafood Joint Stock Company, a tuna processor in Vietnam, after an inspection revealed critical safety violations. The inspection, conducted on Dec. 11-12, 2023, followed a consumer complaint involving histamine poisoning linked to the company’s yellowfin tuna products.

The FDA inspection findings, detailed in Form FDA-483 provided to the company, identified multiple breaches of seafood Hazard Analysis and Critical Control Point (HACCP) regulations. The violations render the firm’s frozen yellowfin tuna products adulterated under the Food, Drug, and Cosmetic Act.

Key violations:

• Inadequate critical limits: The HACCP plan failed to include proper critical limits for histamine control. While the company conducted sampling, the listed procedure was not representative of all fish in the batch. The FDA recommends more thorough testing, particularly from the lower anterior loin of large scombrotoxin-forming fish.
• Monitoring deficiencies: The HACCP plan’s monitoring procedures for receiving critical limits were found to be insufficient. The provided record titled “(Redacted by FDA)” lacked space to document individual observations, making it difficult to verify compliance.
• Failure to address receiving risks: The company’s HACCP plan omitted critical limits for histamine assessment at the fish offloading stage. Proper sensory evaluations for decomposition, such as smell tests, were also missing.
• Non-compliant sampling: The FDA found that the critical limit of “(Redacted by FDA)” did not ensure comprehensive histamine control.

Golden Shrimp provided responses on Dec. 22, 26 and 27, 2023, including updated sampling procedures and supporting photographs. However, the FDA deemed these actions inadequate, as no revised HACCP plan or implementation documentation was included for review.

Ongoing concerns and enforcement:
Golden Shrimp remains on the FDA’s Import Alert #16-105, which flags its products for detention without physical examination due to histamine-related issues.

The FDA emphasized that non-compliance may result in additional enforcement, including continued detention of products under Import Alert #16-120, which addresses firms failing to meet HACCP standards.

For further details, the FDA directed Golden Shrimp to contact its compliance officer or risk facing additional enforcement actions. The agency also urged the firm to use procedures to prevent future violations of food safety regulations.

The full warning letter can be viewed here.

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