# FDA 483 - Genus Lifesciences Inc. - September 20, 2019

Source: https://www.keypedia.com/records/483/genus-lifesciences-inc/c705deab-3810-428e-9d86-946cdbe44d35

> FDA 483 for Genus Lifesciences Inc. on September 20, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Genus Lifesciences Inc.
- Inspection Date: 2019-09-20
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: Genus Lifesciences Inc. in Allentown, PA, was cited for significant deficiencies in its quality control systems during an FDA inspection. The firm failed to thoroughly investigate product discrepancies, including cloudiness, empty bottles, and mold contamination, and lacked adequate written procedures for production and process controls, particularly for packaging validation. Additionally, the company did not submit a required Field Alert Report within the specified timeframe for a significant product issue.

## Related Officers

- [Pharmacy Intern/Certified Pharmacy Technician](https://www.keypedia.com/people/david-a-oluwo/209d60bd-27d8-487b-8249-1c6e44fcc317)

Company: https://www.keypedia.com/companies/genus-lifesciences-inc/ba29ccf4-c220-4a87-ab2e-cd37322d0957

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