FDA 483 - Acme United Corporation - March 28, 2025

Acme United Corporation received a Form 483 citing significant deficiencies in quality control, manufacturing processes, and facility maintenance. The firm failed to conduct thorough investigations into out-of-specification results, lacked adequate testing and validation for its drug products and equipment, and demonstrated poor control over computer systems and equipment identification. These issues indicate a systemic breakdown in ensuring product quality and compliance with cGMP regulations.