FDA 483 - EPM Packaging, Inc. - June 13, 2025

EPM Packaging, Inc. in Lexington, NE, a repackager and relabeler, was inspected by the FDA and received a Form 483 with eight observations. The inspection revealed significant deficiencies in facility separation for penicillin and other drug products, cross-contamination prevention, data integrity, documentation, equipment qualification, employee training, equipment cleaning, pest control records, and quality control unit procedures. These issues indicate a lack of adequate controls to ensure drug product quality and prevent contamination.