FDA WARNING_LETTER - Omar Seafood, Corp - February 10, 2010

The FDA inspected Omar Seafood, Corp. from February 9-10, 2011, identifying serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123, specifically for importers under 21 CFR 123.12. The firm's fresh whole gutted fish, including snapper and grouper, are considered adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions. Key violations include the firm's failure to implement an affirmative step to ensure imported whole gutted snapper and grouper were processed according to FDA's seafood HACCP regulations, as required by 21 CFR 123.12(a)(2)(ii). Additionally, the firm submitted a foreign HACCP plan in Spanish, which violates 21 CFR 123.12(0) requiring plans to be in English. Omar Seafood also failed to provide English documentation verifying their affirmative step for a foreign processor and did not respond to FDA's subsequent request for this additional documentation. The FDA deemed the firm's February 17, 2011, response inadequate. Omar Seafood must respond in writing within fifteen working days, detailing specific corrective actions, including HACCP and importer verification records, and documentation of affirmative step performance. Failure to promptly correct these violations may lead to refusal of admission for imported products, detention without physical examination, product seizure, or injunction. The firm is responsible for ensuring full compliance with the Act and 21 CFR Part 123.