# FDA 483 - PhytogenX, Inc. - February 14, 2019

Source: https://www.globalkeysolutions.net/records/483/phytogenx-inc/440685ec-87b9-4c96-bc55-92609f58e8c4

> FDA 483 for PhytogenX, Inc. on February 14, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: PhytogenX, Inc.
- Inspection Date: 2019-02-14
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: PhytogenX, Inc., a contract manufacturer in Morgantown, PA, was cited during an FDA inspection for failing to document the revalidation of processes. This deficiency occurred in response to significant changes and deviations, including out-of-specification results and changes in cleaning detergents. The lack of proper revalidation documentation indicates a critical gap in the firm's quality control system.

## Related Documents

- [483 - 2020-02-10](https://www.globalkeysolutions.net/records/483/phytogenx-inc/74b6f0a2-88b8-4648-b026-feb4ae03a1e9)
- [483 - 2025-03-27](https://www.globalkeysolutions.net/records/483/phytogenx-inc/51916b2b-ebbf-42c3-8bc4-7b9e5cda1f1c)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/suzanne-m-healy/a4159f42-8968-4dec-89e3-46a5412bc47a)

Company: https://www.globalkeysolutions.net/companies/phytogenx-inc/d1defb06-8ec1-4a7f-8617-7e210e28da3a

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