FDA WARNING_LETTER - Estiatorio Milos - April 28, 2017

On April 27-28, 2017, the FDA inspected Estiatorio Milos, a seafood importer, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), specifically 21 CFR 123.12 for imported fish and fishery products. The firm failed to implement an affirmative step to ensure imported fresh farm-raised sea bream, fresh farm-raised meagre, fresh sardines, ready-to-eat salt-cured grey mullet roe bottarga, and fresh farm-raised sea bass were processed in accordance with the seafood HACCP regulation, as required by 21 CFR 123.12(a)(2)(ii).

This failure 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 firm's response to the FDA 483 was deemed inadequate because submitted documentation, including certificates, did not assure compliance with 21 CFR Part 123.

Failure to correct these violations may result in refusal of admission for imported products under Section 801(a) of the Act (21 U.S.C. § 381