FDA WARNING_LETTER - Ginsberg's Institutional Foods, Inc. - December 09, 2011

The FDA inspected Ginsberg's Institutional Foods, Inc.'s seafood processing facility from December 6-9, 2011, identifying serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 C.F.R. Part 123). This renders their tuna salad, shrimp salad, seafood salad, herring fillets in wine sauce, vacuum-packed smoked salmon, and histamine-forming fish adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate HACCP plans (21 CFR 123.6(c)(3))**: Critical limits for receiving seafood/shrimp/tuna salad, histamine-forming fish, and vacuum-packed smoked salmon were insufficient, especially for products in transit longer than four hours, failing to control *Clostridium botulinum*, pathogen growth, and histamine formation. 2. **Failure to take corrective action (21 C.F.R. 123.7(a))**: Tuna salad shipments exceeding 40°F were not rejected, contrary to the HACCP plan. 3. **Failure to identify food safety hazards (21 C.F.R. 123.6(c)(1))**: The HACCP plan for Herring Fillets in Wine Sauce did not identify histamine formation as a significant