483
EPM Packaging, Inc.FDA 483 - EPM Packaging, Inc. - January 12, 2023
Record Details
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.
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ID · 85005749-ebb0-458d-b41a-84e25d43e0dc