FDA WARNING_LETTER - Thang Nguan Hah Co., Ltd. - May 10, 2013

The FDA inspected Thang Nguan Hah Co., Ltd.'s seafood processing facility in Thailand on May 9-10, 2013, identifying significant violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). An FDA-483 was issued, and the firm's subsequent response was deemed inadequate. The FDA determined the firm's fish sauce products are adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key deficiencies include the failure to: 1) Conduct a hazard analysis identifying all reasonably likely food safety hazards, such as undeclared allergens and pathogen growth/toxin formation (Clostridium botulinum, Staphylococcus aureus). 2) List critical control points to control exposure temperatures for histamine-forming fish species during processing. 3) Establish adequate critical limits at the "Receiving" CCP for histamine formation (testing, internal temperature) and decomposition (defined rejection amount, sensory examination frequency). 4) List adequate monitoring procedures and frequency for histamine levels at the "Receiving" CCP. 5) Implement appropriate corrective actions for deviations from critical limits at the "Receiving" CCP for histamine.

The firm must respond within 15 working days, detailing corrective actions, providing a revised HACCP plan, five days of monitoring records, process flow, and histamine analysis records. Failure to comply may result in refusal of admission of products into the U.S. and detention without physical examination (DWPE) under Import Alert #16-120, and potential re-inspection fees. The letter emphasizes the firm's responsibility for overall compliance with HACCP and GMP regulations.