FDA WARNING_LETTER - Mahi Frozen Foods - April 08, 2022

On August 15, 2022, the FDA issued a Warning Letter to Mahi Frozen Foods in Pakistan following a Foreign Remote Regulatory Assessment conducted from April 4-8, 2022. The assessment revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their fish fillet products adulterated under 21 U.S.C. § 342(a)(4).

Key violations include: 1. **Inadequate Hazard Analysis:** The HACCP plan for "Fish Fillets" failed to list ciguatera fish poisoning (CFP) as a reasonably likely food safety hazard, despite processing associated species (unicorn fish, grouper, red snapper, amberjack). (21 CFR 123.6(a) and (c)(1)) 2. **Missing Critical Control Points (CCPs):** * The plan did not list CCPs for scombrotoxin (histamine) formation at the receiving step, incorrectly identifying it as an Operational Prerequisite Program (OPRP). The firm receives mahi-mahi and amberjack, which are histamine-forming fish, and transports them for approximately one hour. Recommended controls include examining harvest vessel records, checking incoming fish temperatures, performing sensory examinations, and testing for histamine. The OPRP's critical limits for temperature and sensory examination were deemed inadequate.