FDA WARNING_LETTER - Austin Fish Company - September 18, 2009

On December 1, 2009, the FDA issued a Warning Letter to Austin Fish Company following an inspection on September 17-18, 2009. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110).

The FDA determined that the company's Bluefish, Spanish Mackerel, Tuna, Shad, King Mackerel, Amberjack, Dolphin (Mahi Mahi), and Wahoo products were adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

Key violations included: 1. **Inadequate HACCP Plan Critical Limits:** The HACCP plan for scombroid species fish lacked adequate critical limits to control histamine formation. The critical limits "Check that fish arrive from fishermen on ice at proper temp of (b)(4) or below" and "Keep fish stored on ice and under refrigeration" were insufficient. The FDA recommended specific temperature and time controls for fish onboard harvest vessels (e.g., 40°F within 12 hours of death or 50°F within 9 hours of death), internal temperature limits upon receipt (e.g., 50°F or below if delivered 12