FDA WARNING_LETTER - Showa Marine Inc - July 15, 2010

On November 3, 2010, the FDA issued a Warning Letter to Showa Marine Inc. following an inspection from July 6-15, 2010, which revealed serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110). The FDA determined that the firm's pasteurized crab meat and histamine-forming species, including yellowtail (Hamachi) fillets, were adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.

Key violations included: 1. **Lack of a HACCP plan for Clostridium botulinum:** The firm lacked a HACCP plan for refrigerated vacuum-packaged yellowtail fillets to control Clostridium botulinum, a reasonably likely hazard. The provided "Scombroid Fish" plan did not address this hazard or necessary controls, such as maintaining temperatures at or below 38°F. 2. **Failure to implement record-keeping system:** The firm did not record monitoring observations at the receiving and storage critical control points for histamine control in "Scromboid Fish" (including yellowtail) for extended periods (e.g., 7/5/10-6/2/09 for receiving, 7/6/10-4/