# FDA 483 - Bret R. Rutherford, M.D. - January 10, 2023

Source: https://www.keypedia.com/records/483/bret-r-rutherford-md/48d60673-b6e3-4572-b88f-b7b637329564

> FDA 483 for Bret R. Rutherford, M.D. on January 10, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Bret R. Rutherford, M.D.
- Inspection Date: 2023-01-10
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: The New York State Psychiatric Institute received a Form 483 with three observations during an inspection from December 2022 to January 2023. The observations primarily concern failures in clinical trial conduct, including implementing changes without Institutional Review Board (IRB) approval, enrolling subjects who did not meet protocol criteria, and inadequate study monitoring. These issues indicate significant deviations from investigational plan requirements and proper oversight.

## Related Documents

- [WARNING_LETTER - 2023-01-10](https://www.keypedia.com/records/warning_letter/bret-r-rutherford-md/6f478d15-4c3d-4c45-a60e-f1b47fc54ee8)

## Related Officers

- [Omadevi Somai](https://www.keypedia.com/people/omadevi-somai/8a6212bf-2dfa-44ea-bd2f-f2aeb78aa1bd)

Company: https://www.keypedia.com/companies/bret-r-rutherford-md/6d3cd7ed-8400-4e3c-a7fe-f87d75722851

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961