# FDA 483 - Khanjan H. Nagarsheth, MD - August 15, 2025

Source: https://www.globalkeysolutions.net/records/483/khanjan-h-nagarsheth-md/8e2f4e36-2183-4380-8488-014f8560ecdc

> FDA 483 for Khanjan H. Nagarsheth, MD on August 15, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Khanjan H. Nagarsheth, MD
- Inspection Date: 2025-08-15
- Product Type: other
- Office Name: Baltimore District Office
- Summary: An FDA inspection of Khanjan H. Nagarsheth, MD in Baltimore, MD, a clinical investigator, revealed significant issues with the conduct of a clinical study. The firm failed to follow its investigational plan, specifically by not timely reporting serious adverse events (SAEs) and unexpected adverse device events (UADEs) to the sponsor as required by the study protocol. This indicates a serious lapse in clinical trial oversight and patient safety reporting.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/brittany-l-carpenter/600db4d0-0b6b-435f-b511-2ca10f292d5d)

Company: https://www.globalkeysolutions.net/companies/khanjan-h-nagarsheth-md/08e77142-e36c-4a0a-b257-55f6c789dc06

Office: https://www.globalkeysolutions.net/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa