# FDA 483 - J. John Mann, M.D. - December 05, 2023

Source: https://www.keypedia.com/records/483/j-john-mann-md/4724e305-b561-438e-81b8-6882617f65cd

> FDA 483 for J. John Mann, M.D. on December 05, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: J. John Mann, M.D.
- Inspection Date: 2023-12-05
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of New York State Psychiatric Institute, a Sponsor-Investigator, revealed a significant deviation from an investigational plan. The firm failed to conduct an investigation in accordance with the signed statement of investigator and protocol requirements. Specifically, a substantial number of subjects did not have required weekly assessments completed during a critical phase of the study.

## Related Officers

- [Kerun Hardeo](https://www.keypedia.com/people/kerun-hardeo/d6c75a34-ab9b-4541-883d-102c6ec8c131)

Company: https://www.keypedia.com/companies/j-john-mann-md/e448ff32-7899-4a8b-872b-f0796d80fae8

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