FDA cites Chinese canned tuna facility for major HACCP violations following inspection

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. 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.

Rongcheng Jiayuan Food Co. Ltd
Shandong, China

The U.S. Food and Drug Administration issued a warning letter on May 24 — and just posted it for public view — to Rongcheng Jiayuan Food Co. Ltd., based in Shandong, China, following a Nov. 9-10, 2023, inspection. The FDA cited the seafood and low-acid canned food (LACF) facility for multiple violations of seafood Hazard Analysis and Critical Control Points (HACCP) and Emergency Permit Control regulations. An FDA Form 483 was provided at the end of the inspection to detail the issues.

Key Findings:

1. Inadequate HACCP Plan: The HACCP plan for canned tuna omitted key safety controls for Staphylococcus aureus and histamine, which are essential for preventing contamination in seafood products.
2. Unmet Critical Limits: The facility’s critical limits for histamine testing in tuna were insufficient, particularly with composite sampling, which requires stricter limits to ensure safety.
3. Inconsistent Monitoring: Documentation revealed gaps in temperature and processing time records, which are critical for maintaining product safety throughout canning.
4. Poor Corrective Actions: The corrective actions listed for temperature control failures were insufficient, lacking guidance to prevent the recurrence of these hazards.
5. LACF Standards: The facility also failed to monitor water levels in retorts as required and lacked proper screening to prevent debris from entering the water circulation system during canning, heightening the risk of contamination.

The FDA emphasized that failure to correct these issues could lead to the detention of Rongcheng Jiayuan’s products without physical inspection. The agency’s actions reinforce its strict oversight of imported food products, ensuring compliance with U.S. safety standards.

The full warning letter can be found here.

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