Delicias de Espana, Inc. – FDA Warning Letter, Nov 28, 2007

On January 7, 2008, the FDA issued a Warning Letter to Delicias de Espana, Inc., following an inspection from November 26-28, 2007. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123, specifically concerning imported fish and fishery products under 21 CFR 123.12.

The primary violation identified was the firm's failure to implement an affirmative step to ensure that imported Bonito (tuna) in olive oil, packaged in glass jars, was processed in accordance with the seafood HACCP regulation, as required by 21 CFR 123.12(a)(2)(ii). This omission renders the Bonito (tuna) in olive oil adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4), due to being prepared, packed, or held under insanitary conditions.

The FDA warned that failure to promptly correct this violation could lead to further actions, including refusal of admission for imported fish or fishery products under Section 801(a) of the Act, "detention without physical examination," product seizure, and/or injunctions. The firm was required to respond in writing within