FDA WARNING_LETTER - J. Moniz Company Inc. - June 24, 2024

On August 7, 2024, the FDA issued a Warning Letter to Mr. Moniz, owner of a seafood importer establishment at 91 Wordell Street, Falls River, MA, following an inspection on June 24, 2024. 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 cited was the failure to implement an affirmative step to ensure imported raw, fresh, chilled, refrigerated skipjack bonito and fresh, chilled sardines from Portugal were processed in accordance with the seafood HACCP regulation, as required by 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 (21 U.S.C. § 342(a)(4)), as they were prepared, packed, or held under insanitary conditions.

The FDA may take further action, including refusing admission of products under Section 801(a) of the Act, placing them on "detention without physical examination," seizing products, and/or enjoining the firm from further violations. The firm must respond in writing within fifteen working days, outlining specific corrective actions