FDA WARNING_LETTER - Hana Gourmet, Inc. dba Beyond Gourmet - July 09, 2012

The FDA inspected Hana Gourmet, Inc. dba Beyond Gourmet's seafood processing facility from July 5-9, 2012, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). Specifically, the firm's refrigerated marinated anchovy fillets were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) because they were prepared, packed, or held under insanitary conditions.

The significant violation identified was the firm's failure to have and implement a written HACCP plan for refrigerated marinated anchovy fillets to control the food safety hazards of pathogen growth and toxin production, and scombrotoxin (histamine) formation, as required by 21 CFR 123.6(a) and (b). Anchovies are a scombroid species, posing a scombrotoxin hazard. Furthermore, the firm did not ensure appropriate refrigeration during transportation and lacked continuous temperature monitoring for the cooler storing anchovies.

The FDA acknowledged the firm's September 7, 2012, response stating the anchovy fillets were ordered in error and that refrigerated seafood products would no longer be carried. However, the FDA noted that the same product was observed and discussed during a previous inspection in October-November 2010.

The FDA warned of potential further actions, including product