FDA WARNING_LETTER - Euro Gourmet, Inc. - March 19, 2010

On March 8-9, 15, 18-19, 2010, the FDA inspected Euro Gourmet, Inc.'s seafood processing facility in Beltsville, Maryland, and found serious deviations from the seafood Hazard Analysis and Critical Control Points (HACCP) Regulations (21 CFR Part 123). These deviations render the firm's refrigerated ready-to-eat pasteurized crabmeat in hermetically sealed cans and scombroid fishery products, such as marinated anchovies, adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), as they were prepared, packed, or held under insanitary conditions.

Key violations include: 1. **Inadequate Hazard Analysis and HACCP Plans:** * The crab HACCP plan (fresh and pasteurized) failed to list receiving as a critical control point for controlling pathogen growth, toxin formation, and *Clostridium botulinum* growth. * The "Scrombotoxin" (scombroid) HACCP plan for products like marinated anchovies did not list refrigerated storage as a critical control point for controlling pathogen growth and toxin formation, including scombrotoxin (histamine). 2. **Inadequate Critical Limits:** * The "Scrombotoxin" HACCP plan's critical limits for receiving (e.g., "Kept At