# FDA 483 - Rajnish V. Nagarkar, M.D. - May 08, 2024

Source: https://www.keypedia.com/records/483/rajnish-v-nagarkar-md/f10fff9f-061f-4880-8cbd-a4f86c035b58

> FDA 483 for Rajnish V. Nagarkar, M.D. on May 08, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rajnish V. Nagarkar, M.D.
- Inspection Date: 2024-05-08
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Rajnish V. Nagarkar, MD, a clinical investigator in Nashik, Maharashtra, India, revealed a significant issue regarding the conduct of a clinical trial. The inspection found a failure to adhere to Good Clinical Practices and the investigational plan, specifically concerning the timely collection of assessments. This indicates a serious deviation from established study protocols.

## Related Officers

- [investigator](https://www.keypedia.com/people/tawny-l-colling/4ce51467-468c-4271-a98d-4b13c15c0812)

Company: https://www.keypedia.com/companies/rajnish-v-nagarkar-md/de8f2b33-fbc4-4c9b-a4ae-3d9d10666de8

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd