# FDA 483 - Pathogenes, Inc. - November 25, 2022

Source: https://www.keypedia.com/records/483/pathogenes-inc/457602b7-9889-4d46-8069-357924e820f0

> FDA 483 for Pathogenes, Inc. on November 25, 2022. Product: veterinary. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Pathogenes, Inc.
- Inspection Date: 2022-11-25
- Product Type: veterinary
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Pathogenes, Inc. in Reddick, FL, a sponsor of clinical trials, revealed significant deficiencies in study oversight. The firm failed to adequately monitor studies, ensure proper reporting of adverse events, and prevent subjects not meeting inclusion criteria from being exposed to investigational products. These observations indicate a lack of adherence to study protocols and good clinical practices.

## Related Documents

- [483 - 2019-04-24](https://www.keypedia.com/records/483/pathogenes-inc/6c5c21cf-9d10-42fb-8b21-80dc771f8aeb)

## Related Officers

- [Byungja E. Marciante](https://www.keypedia.com/people/byungja-e-marciante/5d1f2927-9017-4ab6-8ad2-521e340ef14f)

Company: https://www.keypedia.com/companies/pathogenes-inc/9d1bbaa5-a59f-4a11-9671-abfc19e3dc76

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6