# FDA 483 - Nucrogene Inc - October 09, 2024

Source: https://www.keypedia.com/records/483/nucrogene-inc/482e5d3d-0a53-4ba9-9cb2-50047cfc6a2a

> FDA 483 for Nucrogene Inc on October 09, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nucrogene Inc
- Inspection Date: 2024-10-09
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Nucrogene Inc, a drug manufacturer in Branchburg, NJ, was cited for significant deficiencies during an FDA inspection. The firm failed to follow its stability testing program, lacked appropriate controls for computer systems including audit trail reviews, and did not complete equipment cleaning validation for tablet presses. Additionally, annual product reviews were not conducted as required.

## Related Officers

- [Alisha B. Patel](https://www.keypedia.com/people/alisha-b-patel/3c106dac-0e0d-41f2-9f7a-69982d4e6579)
- [Pharmacist | Consumer Safety Officer](https://www.keypedia.com/people/victoria-spivak/b43d066f-35c1-4d83-9d38-3ba64d77cf31)

Company: https://www.keypedia.com/companies/nucrogene-inc/501df133-f224-4158-9017-370447fc29a5

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248