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Talk to a SpecialistTalk to a SpecialistDeVere Manufacturing Inc. received a warning letter for manufacturing over-the-counter hand sanitizer products on equipment also used for non-pharmaceutical products such as acidic toilet cleaners, creating unacceptable cross-contamination risks. The FDA inspection (June 2-4, 2025) identified failures to establish and follow adequate written procedures for equipment cleaning and maintenance in violation of Current Good Manufacturing Practice (CGMP) regulations, rendering the firm's drug products adulterated. The company's response commitment to implement cleaning records and validation procedures was deemed inadequate, as CGMP standards prohibit using shared equipment for both drug and non-pharmaceutical manufacturing due to the potential for active ingredient and product residue contamination.