FDA WARNING_LETTER - Good Fish - March 05, 2013

On March 4-5, 2013, the FDA inspected GOOD FISH's facility in Quito, Ecuador, and found serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice regulations (21 CFR Part 110). The firm's fresh fish fillet products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate HACCP Plan (21 CFR 123.6(a) and (c)(2)):** The revised HACCP plan for vacuum-packed fresh fish fillets (mahi-mahi and other histamine-forming fish) failed to list cooler storage as a critical control point for controlling histamine formation, despite the firm's manual stating product can remain in the cooler for up to three days. 2. **Inadequate Critical Limits (21 CFR 123.6(c)(3)):** The revised HACCP plan's critical limit of (b)(4) at the receiving critical control point for internal temperature monitoring was insufficient to control histamine formation. FDA recommends 4.4°C. 3. **Failure to Implement HACCP Procedures (21 CFR 123.6(b)):** The firm did not follow its HACCP plan's