FDA WARNING_LETTER - South Side Seafood Inc - March 26, 2013

On March 25-26, 2013, the FDA inspected South Side Seafood Incorporated in Scranton, PA, and found serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's seafood products, including ready-to-eat (RTE) pasteurized crabmeat and fresh fin fish, are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) because they were prepared, packed, or held under insanitary conditions.

The primary violation is the firm's failure to conduct a hazard analysis and implement a written HACCP plan for RTE pasteurized crabmeat and fresh fin fish products to control the food safety hazard of pathogen/toxin formation, as required by 21 CFR 123.6(a) and (b). The FDA recommends using the "Fish and Fisheries Products Hazard & Controls Guidance: Fourth Edition" to develop an acceptable HACCP plan.

South Side Seafood Incorporated must respond in writing within fifteen working days, outlining specific corrective actions, including HACCP plans and hazard analyses. Failure to promptly correct these violations may result in further action, such as product seizure, injunction against operation, and assessment of re-inspection fees under Section 743 of the Act. The letter also reminds the firm of its responsibility to comply with the Act and Current Good Manufacturing