FDA WARNING_LETTER - Avole, Inc. - June 20, 2008

On June 19-20, 2008, the FDA inspected Avole, Inc.'s seafood processing and importer establishment in San Sebastian, PR, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice regulation (21 CFR Part 110).

The primary violation identified was the firm's failure to implement an affirmative step to ensure imported fish and fishery products, specifically Codfish frying mix from [redacted], were processed in accordance with the seafood HACCP regulation, as required by 21 CFR 123.12(a)(2)(ii). This renders the Codfish frying mix adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

The FDA acknowledged Avole, Inc.'s June 23, 2008, response to the FDA-483, but deemed it inadequate due to a lack of specifics on documentation, implementation timelines for HACCP plan requirements, and a decision regarding the continued importation of the Codfish frying mix.

Avole, Inc. is required to respond in writing within fifteen working days, outlining specific corrective actions, including documentation of HACCP and importer verification records, affirmative steps, and domestic processing activities. Failure to promptly correct these violations may result in refusal of admission of imported products