FDA WARNING_LETTER - Seafood Wholesalers, Limited - March 14, 2013

On February 25-March 14, 2013, the FDA inspected Seafood Wholesalers, Limited, in Houston, Texas, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). These violations render fresh scombroid species, crabmeat, and vacuum-packaged smoked salmon products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate Critical Limits:** The HACCP plan for pasteurized crabmeat had an inadequate critical limit at the receiving CCP, failing to ensure proper temperature control (21 CFR 123.6(c)(3)). 2. **Inadequate Monitoring Frequency:** HACCP plans for ready-to-eat crabmeat, pasteurized crabmeat, and vacuum-packaged smoked salmon had inadequate monitoring frequencies at the storage CCP to control pathogens (21 CFR 123.6(c)(4)). 3. **Failure to Implement Monitoring Procedures:** The firm did not continuously monitor cooler temperatures for scombroid species, crabmeat, and vacuum-packaged smoked salmon as required by their HACCP plans, with significant data gaps observed. Additionally, products were not covered in ice as specified (21 CFR 123.6(b) and (c)(4)). 4. **