FDA WARNING_LETTER - Performance Fisheries Ltd (F/V Agape III) - June 23, 2015

On June 22-23, 2015, the FDA inspected Agape III's seafood processing vessel in Alligator Bay, Bahamas, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123). The firm's "Fresh Stone Crab Claws" were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

The firm's June 29, 2015, response to the FDA-483 was inadequate. Key violations include: 1. **HACCP Plan Deficiency (21 CFR 123.6(a) and (c)(2)):** The HACCP plan for "Fresh Stone Crab Claws" lacked a critical control point for "Cooling" after the cooking stage to control pathogenic bacteria. The firm's SOP for "Cooking and Preservation of Fresh Stone Crabs" outlined cooling procedures, but SOPs cannot replace HACCP plan controls. FDA recommends cooling to below 70°F within two hours and to 40°F within an additional four hours, with internal temperature monitoring. 2. **Inadequate Critical Limits (21 CFR 123.6(c)(3)):** The HACCP plan's listed critical limit was insufficient to control pathogenic bacteria. The SOP indicated other critical factors (b