FDA WARNING_LETTER - Josephson's Smokehouse - December 02, 2013

The FDA inspected a seafood processing facility in Astoria, Oregon, from November 18-22, 2013, with follow-up visits from November 27-December 2, 2013. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering vacuum-packaged, hot-smoked fish products adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions. Additionally, product labeling caused misbranding under 21 U.S.C. § 343(a)(1).

The firm's December 8, 2013, response to the FDA 483 was partially adequate, lacking sufficient evidence of implemented corrections. Key HACCP violations included: 1. Failure to list marinating as a critical control point for pathogen (Staphylococcus aureus) growth and toxin formation in the vacuum-packaged, hot-smoked fish HACCP plan, despite extended marinating times. 2. Absence of critical limits in the HACCP plan for: * Temperature control during extended brining (up to 24 hours) to prevent pathogen growth (Staphylococcus aureus) and histamine formation in scombroid species. * Brining parameters (fish species, portion size) to ensure adequate water phase salt