FDA WARNING_LETTER - Schneider's Fish & Seafood Corp. - December 15, 2010

On December 6-15, 2010, the FDA inspected Schneider's Fish & Seafood Corp. and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). These violations render their salted cod, vacuum-packed tuna loins, S/B Mahi fillets, pasteurized crab, shellfish, and histamine and non-histamine producing products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Lack of HACCP Plan:** No HACCP plan for salted cod to control pathogen growth and toxin formation. 2. **Incomplete Hazard Analysis:** HACCP plans for "Histamine Producing Fish" and "Non Histamine Producing Fish" do not list pathogen growth and parasites as reasonably likely hazards for products intended for raw consumption. 3. **Missing Critical Control Points (CCPs):** * "Pasteurized CRAB" HACCP plan lacks a "Receiving" CCP for pathogen growth and toxin formation (including *Clostridium botulinum*). * "VACUUM PACKED TUNA LOINS" HACCP plan lacks a separate "Storage" CCP to control histamine development after defrosting. * "HISTAMINE PRODUCING Fish" HACCP plan lacks a clear "Storage" CCP to control histamine.