483
Genus Lifesciences Inc.Genus Lifesciences Inc. – FDA 483, Dec 13, 2024
Record Details
Genus Lifesciences Inc. in Allentown, PA, a drug manufacturer, was cited for a significant quality system deficiency during an FDA inspection. The firm failed to thoroughly review unexplained discrepancies and out-of-specification (OOS) results for Levothyroxine Assay in Thyroid Tablets, USP. This included not conducting a scientifically sound study for a sample preparation change and failing to perform an impact assessment on affected samples.
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ID · 61866d28-85f8-4028-a468-9c460b8b0f36
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