# FDA 483 - PhytogenX, Inc. - February 10, 2020

Source: https://www.globalkeysolutions.net/records/483/phytogenx-inc/74b6f0a2-88b8-4648-b026-feb4ae03a1e9

> FDA 483 for PhytogenX, Inc. on February 10, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PhytogenX, Inc.
- Inspection Date: 2020-02-10
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of PhytogenX, Inc., a drug manufacturer in Morgantown, PA, revealed significant deficiencies across multiple areas. Observations included failures in following and documenting established laboratory control mechanisms and test procedures, inadequate investigation of unexplained discrepancies, and a lack of adherence to written quality control unit responsibilities and procedures, including several Standard Operating Procedures.

## Related Documents

- [483 - 2019-02-14](https://www.globalkeysolutions.net/records/483/phytogenx-inc/440685ec-87b9-4c96-bc55-92609f58e8c4)
- [483 - 2025-03-27](https://www.globalkeysolutions.net/records/483/phytogenx-inc/51916b2b-ebbf-42c3-8bc4-7b9e5cda1f1c)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/rachael-oyewole/bc642edb-4124-4cd1-b979-0d752ead1bfd)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/christina-k-theodorou/3c18d958-14de-4f25-9fbd-7358205155f7)

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