FDA 483 - Tenco Assemblies, Inc. - August 07, 2024

Tenco Assemblies, Inc. in Morrisville, PA, a repackager and relabeler, was inspected by the FDA from August 5-7, 2024. The inspection revealed two significant observations related to inadequate record-keeping for equipment maintenance and improper storage conditions for reserve drug product samples. These issues indicate potential non-compliance with good manufacturing practices for drug products.