According to FDA’s Data Dashboard, the most frequently cited violation by FDA investigators in...
Warning Letter Highlights Importance of CGMP Requirements
By Ryan Maus
Prerequisite programs provide the basic environmental and operating conditions necessary to support the food safety management program. They include good manufacturing practices (GMPs), sanitation, pest control, and other programs. FDA’s Current Good Manufacturing Practice (CGMP) requirements are part of the Preventive Controls rule and are codified in 21 CFR 117 Subpart B, Sections 117.10 - 117.110. Failure to meet these requirements comprise nearly half of FDA’s annual top 10 food facility citations. A recently published warning letter highlights the prerequisite program violations that commonly rise to the top of FDA’s annual list of citations. A warning letter was issued to a wholesale ready-to-eat (RTE) bakery on December 26, 2023. FDA cited the following CGMP violations in their investigation:
• Inspectors found an unclean storage shelf and pallet in the cooler, standing dirty water in the packaging room, pitted unsealed floors throughout the facility, and a dishwashing machine with apparent mineral and food residue buildup. In violation of 21 CFR 117.35(a) - Sanitary operations - Plant maintenance. This citation ranks #2 in FY 2023.
• Inspectors found that employees wearing gloves touched non-food contact surfaces (including trash) prior to handling ready-to-eat product while wearing the same gloves. In violation of 21 CFR 117.10 Personnel. This citation ranks #5 in FY 2023.
• Inspectors found that the plant is not constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept clean and kept in good repair.
In violation of 21 CFR 117.20(b) - Plant construction and design. This citation ranks #10 in FY 2023.
• Inspectors found employees using a dirty metal scoop, spatula, and a cake slicing blade that were not cleaned
prior to use and had food residues on them. In violation of 21 CFR 117.35(d) - Sanitary operations, Sanitation of food-contact surfaces.
• Inspectors found food residue on the underside, spindle, and rear splash guard of the stand mixers; the base, underside, locking lever, and wheels of the batter dispensing machine; and the top shelf extending over the stove, the stove’s backsplash, and the exhaust hood.
In violation of 21 CFR 117.35(e) - Sanitary operations, Sanitation of non-food-contact surfaces.
Category:
▪Hazard Analysis and Risk-Based Preventive Controls
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