FDA WARNING_LETTER - Frito Lay Inc - June 01, 2015
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On May 26-27 and June 1, 2015, an FDA inspection of Frito-Lay, Inc.'s snack food manufacturing facility in Pulaski, Tennessee, revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). These conditions render food products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, due to insanitary conditions potentially leading to contamination.
Violations included: 1. **Poor Facility Maintenance (21 CFR 110.35(a)):** Numerous issues such as 16 buckets collecting roof leaks over exposed product, worn and soiled equipment wash bay with a 3-inch hole, plastic-wrapped and duct-taped air ducts over food, peeling paint and water stains on ceilings and walls, chipping paint above exposed ready-to-eat product, leaking water hose bibs, leaking equipment (votator, transfer pump, cheese filling machines, cooking oil piping), exposed wiring, corroded fan shrouds, and widespread food debris/dust on surfaces and mezzanine floors. 2. **Inadequate Facility Construction (21 CFR 110.20(b)(4)):** Condensate and water stains observed on piping directly above ready-to-eat product. 3. **Insufficient Cleaning of Food Contact Surfaces (21 CFR 11
ID · 54ae2025-29a1-48b4-8781-a0e96834a47d
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