# FDA 483 - FORDOZ PHARMA CORPORATION - March 17, 2023

Source: https://www.globalkeysolutions.net/records/483/fordoz-pharma-corporation/ab7bcae2-5d05-41b5-85f7-5e621c3dde1a

> FDA 483 for FORDOZ PHARMA CORPORATION on March 17, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: FORDOZ PHARMA CORPORATION
- Inspection Date: 2023-03-17
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: FORDOZ PHARMA CO. in East Windsor, NJ, a sterile drug manufacturer, was cited for significant deficiencies across its manufacturing operations. Observations included inadequately designed and qualified equipment, unsuitable building construction and maintenance, and failures in aseptic process simulations and warehousing procedures. These issues indicate a lack of control over critical aspects of sterile drug production and storage.

## Related Documents

- [483 - 2025-11-12](https://www.globalkeysolutions.net/records/483/fordoz-pharma-corporation/94433e44-902f-41f5-82b3-f97e036a8d87)

## Related Officers

- [Consumer Safety Officer at FDA](https://www.globalkeysolutions.net/people/alice-s-tsao/b6d72ceb-de7c-413d-b104-cac3b075c170)
- [Investigator](https://www.globalkeysolutions.net/people/pushpa-s-jayasekara/cfd7d22f-b4c2-4002-ae18-b5435815d27d)

Company: https://www.globalkeysolutions.net/companies/fordoz-pharma-corporation/d5bae860-733e-4866-86c1-e97c3087f8af

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