FDA WARNING_LETTER - Chilemar, Inc - May 31, 2017

On June 29, 2017, the FDA issued a Warning Letter to Eugenio Sanchez, owner of Chilemar, Inc., following an inspection on May 31, 2017. 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 comply with 21 CFR 123.12(a)(2), as Chilemar, Inc. did not have or implement written verification procedures, product specifications, and an affirmative step to ensure imported fish were processed in compliance with the Seafood HACCP regulation. This deficiency was specifically noted for Frozen Mahi Mahi portions and Frozen Cooked Whole Shell Mussels (Vacuum Packed) imported in February 2017.

As a result, the aforementioned products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(4)), indicating they were prepared, packed, or held under insanitary conditions potentially injurious to health.

The FDA acknowledged a June 15, 2017, response from Chilemar, Inc. indicating efforts to correct deficiencies, but experiencing delays due to document translation. The letter warns of