Loading…
Acme United Corporation's drug manufacturing facility was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of topical over-the-counter drug products, including sterile and non-sterile antiseptic wipes, rendering these products adulterated. The company failed to design and adequately control its water system used in drug formulation, resulting in repeated isolation of the pathogenic microorganism Burkholderia cepacia in the holding tank and at points of use, and did not thoroughly investigate batch discrepancies or equipment failures as required. Additional violations included failure to use equipment of appropriate design and adequate size suitable for manufacturing operations and proper cleaning and maintenance.