FDA WARNING_LETTER - Alby's Seafood, Inc. - June 12, 2012

On October 15, 2012, the FDA issued a Warning Letter to Alby's Seafood, Inc. following an inspection from June 6-12, 2012. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their drum, flounder, and canned pasteurized crabmeat adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Lack of HACCP Plan:** The firm lacked a HACCP plan for drum or flounder to control environmental chemical contaminants and pesticides (21 CFR 123.6(a), (b)). 2. **Inadequate Critical Limits:** The HACCP plan for canned pasteurized crabmeat had an inadequate critical limit of refrigerated temperature less than or equal to (b)(4)°F at receiving, insufficient to control *Clostridium botulinum*. The FDA guidance recommends specific critical limits for refrigerated or iced products (21 CFR 123.6(c)(3)). 3. **Failure to Implement Monitoring Procedures:** The firm did not follow its HACCP plan's monitoring procedures for canned pasteurized crabmeat storage, failing to document cooler temperatures (e.g., 48°F observed on June 6-7, 2012