FDA WARNING_LETTER - A G Specialty Foods, Inc - June 08, 2010

On June 2-4 and 8, 2010, the FDA inspected a seafood processing facility in Gladstone, Oregon, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice (CGMP) regulation for foods (21 CFR Part 110). The firm's tuna fish sandwiches, both modified atmosphere packaged (MAP) and non-MAP, were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.

Key violations included: 1. **Lack of HACCP Plan for MAP Tuna Sandwiches:** No HACCP plan existed to control histamine formation, pathogen growth (including *Clostridium botulinum* toxin), and allergens for tuna salad sandwiches in oxygen-impermeable packaging. 2. **Incomplete Hazard Analysis:** The HACCP plan for non-MAP tuna fish sandwiches failed to list histamine formation and allergenic substances (eggs, soy, wheat, milk) as reasonably likely food safety hazards. 3. **Inadequate Critical Limits:** The critical limit for refrigeration in the non-MAP tuna sandwich HACCP plan was insufficient to control pathogen growth and histamine formation. 4. **Missing Critical Control Points:** The non-MAP tuna sandwich HACCP plan did not include in-process refrigerated storage as a critical