FDA WARNING_LETTER - Johnson Sea Products, Inc - March 26, 2010

On March 16-18, 22, and 26, 2010, an FDA investigator inspected Johnson Sea Products, Inc. in Coden, Alabama, and found serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (CGMP) regulation (21 CFR Parts 123 and 110). The firm's stuffed seafood products are adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) due to insanitary conditions.

A sample of (b)(4) collected during the inspection confirmed rodent gnawed holes and excreta pellets on multiple bags, and rodent excreta pellets in the contents of one bag, rendering the product adulterated under Section 402(a)(3) of the Act.

Significant violations include inadequate monitoring of sanitation conditions and practices, specifically pest exclusion (21 CFR 123.11(b)). Evidence included: 14 bags of (b)(4) with dead insects, 2 bags with live insects, 1 bag with rodent excreta pellets, and 2 bags with rodent gnawed holes in the raw ingredient storeroom. Additionally, 36 rodent excreta pellets were observed along the south wall of the storeroom, a live fly was on a tote of clean crab