FDA WARNING_LETTER - Merex Inc - February 22, 2011

On February 21-22, 2011, the FDA inspected Merex Inc.'s seafood processing facility in Halifax, Canada, 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 salted fish adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

The firm failed to have HACCP plans for refrigerated, smoked herring (to control histamine and pathogen growth/toxin formation) and refrigerated dried salted cod, Pollock, hake, cusk, and ling fish (to control undeclared allergens and pathogen growth/toxin formation, specifically Clostridium botulinum and Staphylococcus aureus), violating 21 CFR 123.6(a) and (b).

Additionally, Merex Inc. did not sufficiently monitor sanitation conditions, violating 21 CFR 123.11(b). Evidence included rusty fans with dirt blowing over products in coolers, flaking rust on shelving above raw materials, and mold-like growth and rust marks on the ceiling of the finished product cooler, which also contained raw materials.

The FDA acknowledged Merex Inc.'s March 7, 2011, response to the FDA 483, but deemed it inadequate due to a lack