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Talk to a SpecialistTalk to a SpecialistKath Khemicals LLC was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of over-the-counter drug products, specifically McD Foaming Antibacterial Hand Soap and McD Anti-Microbial Handwash, rendering these finished pharmaceuticals adulterated. During the March 31 – April 3, 2025 inspection, the FDA found that the company failed to conduct appropriate laboratory testing on finished batches prior to release, including testing for identity, strength of active ingredients, and freedom from objectionable microorganisms, as required by 21 CFR 211.165(a) and (b). Notably, batch records demonstrated inconsistent sampling practices, with the firm failing to document whether samples were pulled for final release testing on products like McD Anti-Microbial Handwash batch 010726.