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Talk to a SpecialistTalk to a SpecialistEnviroServe Chemicals & Cleaners Ltd., an over-the-counter drug manufacturer in Canada, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, resulting in adulterated drug products that do not conform to required manufacturing standards. The company failed to conduct identity verification testing for drug components and did not validate or establish the reliability of component suppliers' testing. Additionally, SOPURE ANTISEPTIC SKIN CLEANSER was marketed as an unapproved new drug and misbranded in violation of federal law. The FDA's inspection was initiated following a June 16, 2022 records request under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act.