FDA 483 - Genus Lifesciences Inc. - December 13, 2024

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.