FDA WARNING_LETTER - Frog Island Seafood Inc - August 04, 2011

An FDA inspection of Frog Island Seafood Inc. on August 3-4, 2011, revealed significant violations. Environmental swabs collected during the inspection tested positive for Listeria monocytogenes (L. monocytogenes) in six locations, including a direct food-contact surface (red dip basket) and various floor surfaces and standing water in the cooked crab cooler. These findings indicate poor sanitary practices and led the FDA to determine that the foods manufactured at the facility are adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions. Additionally, investigators observed a Current Good Manufacturing Practice (CGMP) violation: condensation in the cooked crab cooler directly above a cart of cooked crabs, which violates 21 CFR 110.20(b)(4) requiring facilities to prevent drip or condensate from contaminating food or food-contact surfaces. The firm's August 18, 2011, response, proposing to no longer place crabs under the cooling unit, was deemed inadequate as it does not eliminate the contamination potential. The FDA requires prompt corrective actions, establishment of preventive procedures, and a written response within fifteen working days detailing specific steps and providing documentation. Failure to comply may result in regulatory actions like seizure or injunction.