FDA WARNING_LETTER - Marfish, Inc. - December 18, 2013

On December 17-18, 2013, the FDA inspected Marfish, Inc.'s seafood processing facility in Miami, Florida, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110). These violations render their fresh aquacultured Sea Bass and refrigerated canned Pasteurized Crabmeat adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to implement HACCP monitoring procedures (21 CFR 123.6(b) and (c)(4)):** Marfish, Inc. lacked records for monitoring and verifying the receiving CCP for canned pasteurized crabmeat since July 18, 2013, and did not keep written records of ice checks at the Storage in Cooler CCP since May 29, 2013. Calibration records for thermometers used for receiving temperature checks were also absent since July 6, 2012. These are repeat observations from previous inspections. 2. **Failure to monitor sanitation conditions (21 CFR 123.11(b)):** The firm did not sufficiently monitor safety of water, hand-washing facilities, food contact surfaces, toxic compound labeling/storage, and pest exclusion. Specific