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Talk to a SpecialistTalk to a SpecialistSanitizer Supply LLC, a drug manufacturer of over-the-counter hand sanitizers and sanitizing wipes, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. The FDA inspection in March 2022 identified that the firm failed to perform required potency and microbial testing on benzalkonium chloride-based hand sanitizing wipes before releasing them for distribution, in violation of 21 CFR 211.165(a). The company released products based on undisclosed procedures without final product testing results, rendering the drug products adulterated. Although the firm acknowledged the violations and indicated plans to cease manufacturing operations in their April 2022 response, they did not provide specific corrective action evidence to address the FDA's observations.