# Nucrogene Inc – FDA 483, Jul 27, 2026

Source: https://www.keypedia.com/records/483/nucrogene-inc/ca861bb9-b1cb-444c-95ae-4f49cc19fbda

> FDA 483 for Nucrogene Inc on July 27, 2026. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Nucrogene Inc
- Inspection Date: 2026-07-27
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Nitrogene Inc, a drug manufacturer in Branchburg, NJ, revealed significant deficiencies in their quality system. The firm was cited for inadequate process validation, unvalidated equipment cleaning procedures, insanitary conditions, lack of equipment qualification, compromised data integrity, and insufficient computer system controls. These issues indicate a severe lack of control over critical manufacturing processes and data.

## Related Documents

- [483 - 2024-10-09](https://www.keypedia.com/records/483/nucrogene-inc/482e5d3d-0a53-4ba9-9cb2-50047cfc6a2a) — date: October 9, 2024

## Related Officers

- [Yvins Dezan](https://www.keypedia.com/people/yvins-dezan/e9fd12e6-c090-4eb6-bc78-8b80e8a90946)
- [Robin P. Mathew](https://www.keypedia.com/people/robin-p-mathew/35f4a085-58b8-4208-a648-ef2d533e1ece)
- [Drug Investigator](https://www.keypedia.com/people/jessica-s-estriplet/b7152ec3-6e1b-45aa-840e-7147f357aea2)

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