FDA WARNING_LETTER - Rohr Fish, Inc. - May 18, 2010

On September 21, 2010, the FDA issued a Warning Letter to Rohr Fish, Inc. following an inspection from April 19 to May 18, 2010. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110).

The FDA found that Rohr Fish, Inc.'s canned pasteurized crab meat, vacuum-packed smoked fish, histamine-forming fish, non-histamine-forming fresh fish, and ready-to-eat seafood salad and dip products were adulterated because they were prepared, packed, or held under insanitary conditions.

Key violations included: 1. **Inadequate Critical Limits:** HACCP plans for vacuum-packed smoked fish and ready-to-eat salads/dips listed a 45°F critical limit for receiving and storage, which is insufficient to control *Clostridium botulinum* or general pathogen growth. A temperature of 40°F or below is required. 2. **Inadequate Monitoring Procedures and Frequencies:** * For vacuum-packed smoked fish and ready-to-eat salads/dips, temperature checks at receiving were inadequate for products with extensive transit times; continuous monitoring (e.g., data loggers) was recommended. * Storage monitoring for these products