FDA WARNING_LETTER - Great Oceans, LLC - October 18, 2011

An FDA inspection of Great Oceans, LLC, a seafood importer located in Jericho, New York, was conducted on October 12 & 18, 2011. The inspection revealed a serious violation of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, specifically Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123), concerning imported fish and fishery products. The firm failed to implement an affirmative step to ensure that imported refrigerated fresh Yellowfin Tuna and Big Eye Tuna were processed under conditions compliant with 21 CFR Part 123, as required by 21 CFR § 123.12 (a)(2)(ii). This deficiency renders the imported tuna adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. The FDA requires Great Oceans, LLC to respond in writing within fifteen working days, detailing specific corrective actions taken to address these violations. The response must include supporting documentation such as HACCP and importer verification records, and evidence of affirmative step performance. Failure to promptly correct these issues may lead to further regulatory actions, including refusal of admission for imported products, detention without physical examination, product seizure, and/or injunctions against the firm. The company is responsible for ensuring full compliance with the Act and all applicable regulations for imported seafood.