Sea World, Inc. – FDA Warning Letter, Mar 27, 2012

On May 1, 2012, the FDA issued a Warning Letter to Sea World, Inc. following an inspection of their seafood warehouse in St. Thomas, VI, from March 26-27, 2012. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their seafood products, including pasteurized canned crabmeat, adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. Failure to conduct a hazard analysis and implement a written HACCP plan for pasteurized canned crabmeat to control *Clostridium botulinum* growth and toxin formation (21 CFR 123.6(a) and (b)). This also applies to other received seafood products (frozen and fresh). 2. Lack of a HACCP plan listing critical control points and critical limits for any products, including fresh and frozen seafood, specifically for temperature limits during receiving and storage to control pathogen growth (21 CFR 123.6(c)(2) and (c)(3)). 3. Failure to calibrate process-monitoring instruments and review calibration records (21 CFR 123.8(a)(2) and (a)(3)). 4. Failure to maintain sanitation control records documenting monitoring activities (2