Rongcheng Jiayuan Foodstuffs Co., Ltd. – FDA Warning Letter, Nov 10, 2023

On May 31, 2024, the FDA issued a Warning Letter to Rongcheng Jiayuan Foods (3rd Workshop) Co., Ltd. following an inspection on November 9-10, 2023. The inspection revealed serious deviations from Seafood HACCP (21 CFR Part 123) and Low Acid Canned Foods (LACF) regulations (21 CFR Part 108 and 113).

Key violations include: - **Seafood HACCP:** The firm's HACCP plan for canned tuna failed to identify Staphylococcus aureus growth and toxin formation as a reasonably likely hazard. Critical limits for histamine at the receiving CCP were inadequate, specifically regarding composite sample testing and sensory evaluation for decomposition. Monitoring procedures for cumulative processing time and temperature were not implemented as listed in the HACCP plan. Corrective actions for various critical control points were deemed inappropriate, lacking details on addressing the cause of deviations. - **LACF Regulations:** The firm did not record retort water levels at sufficient intervals to ensure adequacy, and suction outlets in the circulating system lacked proper non-clogging screens.

These violations render the firm's canned tuna products adulterated under 21 U.S.C. § 342(a)(4). The FDA has not received a response to the FDA-483 issued during the inspection. The firm must respond in writing within 15 working days, outlining