FDA WARNING_LETTER - Bennett's Inc - October 09, 2015
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On September 23-24, October 6 and 9, 2015, the FDA inspected Bennett's, Inc., a seafood processing facility in Ripley, Mississippi. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123) and Current Good Manufacturing Practice (21 CFR 110), rendering their fishery products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.
Key violations include: 1. **Lack of HACCP Plan:** The firm failed to conduct a hazard analysis or implement a written HACCP plan for fresh catfish, frozen shrimp, frozen oysters, and frozen crawfish tails to control pathogenic bacteria growth and toxin formation from time and temperature abuse (21 CFR 123.6(a) and (b)). 2. **GMP Deficiencies:** Numerous Current Good Manufacturing Practice violations were observed (21 CFR 123.11(b)), including: * Uncovered breakable light bulbs directly over exposed food in the (b)(4) and freezer. * Cases of frozen catfish stored directly against the wall in the (b)(4) freezer. * Build-up of frozen condensate on the floor under fans in the (b)(4) freezer. * Improper rubbish storage, with
ID · 32b545e6-6ca2-47bd-992c-b25999ec244b
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