FDA WARNING_LETTER - Airline Seafood, Inc. - November 12, 2010

On November 8 and 12, 2010, the FDA inspected Airline Seafood, Inc. and found serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110). These violations render the firm's fresh refrigerated cooked ready-to-eat crabmeat adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

Key violations include: 1. **Lack of HACCP Plan:** The firm lacked a HACCP plan for fresh refrigerated cooked ready-to-eat crabmeat to control *Clostridium botulinum*, violating 21 CFR 123.6(b). 2. **Inadequate Sanitation Monitoring:** The firm failed to sufficiently monitor the condition and cleanliness of food contact surfaces, as evidenced by dirty, wet plastic totes with accumulated material from previous processing, violating 21 CFR 123.11(b) and 21 CFR Part 110. 3. **Inadequate Critical Limit:** The HACCP plan for Histamine Prone Fish listed an inadequate critical limit of (b)(4) at the receiving critical control point, insufficient to control histamine formation, violating 21 CFR 123.6(c)(3). FDA recommends transportation records showing fish held