# FDA 483 - PhytogenX, Inc. - March 27, 2025

Source: https://www.keypedia.com/records/483/phytogenx-inc/51916b2b-ebbf-42c3-8bc4-7b9e5cda1f1c

> FDA 483 for PhytogenX, Inc. on March 27, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PhytogenX, Inc.
- Inspection Date: 2025-03-27
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: Phytogenx, Inc. in Morgantown, PA, was inspected and received a Form 483 with two observations related to quality control. The inspection revealed deficiencies in component testing, specifically for glycerin, and inadequate finished product microbial testing for non-sterile aqueous drug products. These issues indicate potential risks to product quality and patient safety.

## Related Documents

- [483 - 2019-02-14](https://www.keypedia.com/records/483/phytogenx-inc/440685ec-87b9-4c96-bc55-92609f58e8c4)
- [483 - 2020-02-10](https://www.keypedia.com/records/483/phytogenx-inc/74b6f0a2-88b8-4648-b026-feb4ae03a1e9)

## Related Officers

- [Stephenie M. Ortiz](https://www.keypedia.com/people/stephenie-m-ortiz/b0923b14-b153-4893-8eb2-f5e6b1fd2041)

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

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