Fish Cove, Inc. – FDA Warning Letter, Jul 21, 2010

On November 8, 2010, the FDA issued a Warning Letter to Fish Cove, Inc. following an inspection from July 13-21, 2010, at their Syracuse, NY facility. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their breaded haddock adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate Hazard Analysis (21 CFR 123.6(a) and (c)(1)):** The HACCP plan for breaded haddock failed to list allergenic substances as a reasonably likely food safety hazard. 2. **Missing Critical Control Point (21 CFR 123.6(a) and (c)(2)):** The HACCP plan for breaded haddock did not include refrigerated storage as a critical control point to control *Staphylococcus aureus* toxin formation.

Additionally, Fish Cove, Inc. failed to register their facility with the FDA, a violation of Section 415 of the Act (21 U.S.C. § 350d) and 21 CFR Part 1, Subpart H. Failure to register is a prohibited act under Section 301(dd) of the Act.