# FDA 483 - Susheel Kodali, M.D. - November 26, 2025

Source: https://www.keypedia.com/records/483/susheel-kodali-md/95e95928-078c-4ac3-9a9e-0c6517856b06

> FDA 483 for Susheel Kodali, M.D. on November 26, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Susheel Kodali, M.D.
- Inspection Date: 2025-11-26
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Susheel K. Kodali, MD, Clinical Investigator, revealed a significant failure to report unanticipated serious adverse device effects to the sponsor within the required 10 working days. Four serious adverse events involving three subjects were identified as not being reported in a timely fashion, with delays ranging from 55 to 1244 days. This indicates a serious lapse in regulatory compliance for clinical investigations.

## Related Officers

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

Company: https://www.keypedia.com/companies/susheel-kodali-md/c44af65c-0d10-41a4-aaa8-3ba67ce6ab2a

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