FDA WARNING_LETTER - Sea World, Inc. - February 28, 2008

On February 27-28, 2008, an FDA inspection of Sea World, Inc.'s seafood importer establishment in Guaynabo, Puerto Rico, revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123. Specifically, the firm failed to implement an affirmative step to ensure imported snapper, grouper, mahi-mahi, conger (eel), and corvine were processed in accordance with 21 CFR 123.12(a)(2)(ii). This deficiency renders the imported products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Additionally, the facility failed to register with the FDA as required by Section 415 of the Act and 21 CFR Part 1, Subpart H, which constitutes a prohibited act under Section 301(dd) of the Act. The FDA mandates immediate registration. The firm must respond in writing within fifteen working days, detailing corrective actions, including HACCP and importer verification records, and explaining any delays. Failure to correct these violations may result in refusal of admission for imported products, detention without physical examination, product seizure, and/or injunction.