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

Source: https://www.keypedia.com/records/483/genus-lifesciences-inc/61866d28-85f8-4028-a468-9c460b8b0f36

> FDA 483 for Genus Lifesciences Inc. on December 13, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Genus Lifesciences Inc.
- Inspection Date: 2024-12-13
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: 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.

## Related Documents

- [EIR - 2024-12-13](https://www.keypedia.com/records/eir/genus-lifesciences-inc/48443989-a2aa-4cea-85dd-8361d9cad6a4)

## Related Officers

- [Evan Tong](https://www.keypedia.com/people/evan-tong/2cd81562-886c-4672-9522-a07fb1b33ef2)
- [Mindy M. Chou](https://www.keypedia.com/people/mindy-m-chou/3d0e74bf-ad6b-48b5-8b72-cbb29e9c9ce5)
- [Azeezat M. Lawal](https://www.keypedia.com/people/azeezat-m-lawal/6068345c-a8c8-438e-9b59-f7fc35370a59)
- [Paige R. McCoy](https://www.keypedia.com/people/paige-r-mccoy/d871e1a3-ec99-4c8b-a12f-477d7719f09a)

Company: https://www.keypedia.com/companies/genus-lifesciences-inc/1a34ff6d-a56f-46b7-ba97-c1bbcf1098b0

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8