# FDA 483 - Jose D. Gutierrez, MD, MPH - January 10, 2025

Source: https://www.keypedia.com/records/483/jose-d-gutierrez-md-mph/eeb32c2b-1cfc-40cb-b0ba-4688e6ffc812

> FDA 483 for Jose D. Gutierrez, MD, MPH on January 10, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jose D. Gutierrez, MD, MPH
- Inspection Date: 2025-01-10
- Product Type: drugs
- Office Name: New York District Office
- Summary: An FDA inspection of Columbia University Irving Medical Center in New York identified significant deficiencies in the conduct of clinical investigations. The firm failed to submit required annual IND reports, adequately monitor ongoing investigations, and maintain complete case histories for study subjects. Additionally, the inspection revealed failures in the timely reporting of serious adverse events to the sponsor.

## Related Officers

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

Company: https://www.keypedia.com/companies/jose-d-gutierrez-md-mph/b82369d0-b204-4d0d-8798-64b3c1c40f49

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d