FDA 483 - EPM Packaging, Inc. - August 22, 2025

EPM Packaging, Inc. in Lexington, NE, received five observations during an FDA inspection, primarily concerning inadequate separation of penicillin packaging operations from other drug products. The firm was cited for significant cross-contamination risks due to shared HVAC systems, personnel access, and a lack of validated cleaning and testing procedures. Additionally, the inspection revealed a critical absence of essential written procedures for production controls and quality unit responsibilities.