Rongcheng Jiayuan Food Co. of Shandong Province, China, has received a warning letter from the US Food and Drug Administration (FDA)

U.S. FDA Flags Chinese Seafood Facility for Violations in Canned Tuna Processing

CHINA
Friday, November 15, 2024, 00:10 (GMT + 9)

The U.S. Food and Drug Administration (FDA) conducted an inspection of the seafood and low-acid canned food (LACF) facility, Rongcheng Jiayuan Foods (3rd Workshop) Co., Ltd., located at No. 299 Fenghuang Road, Rongcheng, Weihei, Shandong Province, China, on November 9 and 10, 2023.

This inspection revealed significant deviations from the FDA's Seafood HACCP regulation (21 CFR Part 123), Emergency Permit Control regulation (21 CFR Part 108), and Low Acid Canned Foods regulation (21 CFR Part 113). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations, detailing the compliance issues identified. As of this date, the FDA has not received a response addressing the observations documented at the facility.

Under 21 CFR 123.6(g), a fish or fishery product processor is required to establish and implement a HACCP plan that complies with Part 123 and operates in accordance with its requirements. Failure to meet these standards renders fish or fishery products adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). As a result, the facility's canned tuna products are considered adulterated, as they have been prepared, packed, or held under conditions that could potentially compromise consumer safety. The FDA’s website (www.fda.gov) provides access to the Act, Seafood HACCP regulations, and the Fish and Fisheries Products Hazards and Controls Guidance (4th Edition).

As an LACF product manufacturer exporting to the United States, the facility is also required to comply with the Act and its associated regulations. The Emergency Permit Control regulations, established under section 404 of the Act (21 U.S.C. § 344), stipulate that a temporary emergency permit may be required for thermally processed low-acid foods in sealed containers and acidified foods if the processor fails to meet the requirements of 21 CFR Part 108.25, including the necessary registration, process information filings, and compliance with mandatory provisions in 21 CFR Part 113. Regulations for LACF processing are specifically outlined in 21 CFR Part 108 and 21 CFR Part 113.

According to these regulations, a commercial processor that does not fulfill all mandatory requirements under 21 CFR Part 108.25 and 21 CFR Part 113 may be subjected to emergency permit control provisions outlined in section 404 of the Act (21 U.S.C. § 344). For imported products, 21 CFR 108.25(j) allows the FDA to refuse admission of a commercial processor's products under section 801 of the Act (21 U.S.C. § 381), in place of issuing an emergency permit. Non-compliance with these provisions renders the facility’s LACF food products adulterated under section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4)). Additional information on the Act and Acidified Food regulations is available on the FDA’s website at www.fda.gov.

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