483
Tenco Assemblies, Inc.Tenco Assemblies, Inc. – FDA 483, Aug 7, 2024
Record Details
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.
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ID · d88211ad-8d5b-44c8-8f21-fccb1fc77008
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