FDA 483 - EPM Packaging, Inc. - January 12, 2023

EPM Packaging Inc, a repackager/relabeler in Lexington, NE, was inspected by the FDA from January 10-12, 2023. The inspection revealed significant deficiencies in batch production and control records, inadequate sampling and supplier qualification for containers and closures, and a lack of established written procedures for production, process controls, equipment qualification, and change management. These issues indicate a general lack of control over critical manufacturing processes.