Genus Lifesciences Inc.December 13, 2024

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

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore Genus Lifesciences Inc.

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.

Company: Genus Lifesciences Inc.
Inspection Date: December 13, 2024
Product Type: Drugs
Office: Philadelphia District Office
People: Evan Tong
Mindy M. Chou
Azeezat M. Lawal
Paige R. McCoy

Open in Dashboard

ID · 61866d28-85f8-4028-a468-9c460b8b0f36