FDA 483 - DeVere Company, Inc. - June 04, 2025

DeVere Company, Inc. in Janesville, WI, an OTC drug manufacturer, was cited for significant deficiencies across its quality system during an FDA inspection. The firm failed to follow its stability testing program, lacked adequate written procedures and controls for its quality unit and manufacturing processes, and did not ensure proper laboratory controls, including testing of raw materials and finished products for impurities and microbial contamination. These issues indicate a systemic breakdown in ensuring the identity, strength, quality, and purity of its OTC antimicrobial hand sanitizer drug products.