FDA WARNING_LETTER - American Seafood Company Inc - August 05, 2010

On August 3-5, 2010, the FDA inspected Choice Food Group, Inc.'s seafood processing facility, American Seafood Company, Inc., in Memphis, Tennessee, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123) and Current Good Manufacturing Practice (CGMP) regulation (21 CFR 110). These violations render their seafood products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Lack of HACCP Plans:** No HACCP plans for raw, refrigerated tuna (not vacuum-packaged), vacuum-packaged raw, refrigerated tuna, and raw, refrigerated salmon to control hazards like pathogens, histamine formation, and *Clostridium botulinum*. 2. **Inadequate Monitoring Implementation:** Failure to implement continuous temperature monitoring at the Storage critical control point for Scombroid or Other Histamine Producers, as records lacked temperature readings. 3. **Inadequate Critical Limits:** HACCP plans for Fresh Crabmeat, Pasteurized Crabmeat, and Shellfish listed inadequate temperature critical limits (45°F) for pathogen control; FDA recommends 40°F or below. The plan for Scombroid or Other Histamine Producers lacked a critical limit at Receiving for transit temperature control, and "Continuing certificates of guarantee" were deemed insufficient. 4