# FDA 483 - Diwakar Davar, M.D. - October 19, 2023

Source: https://www.globalkeysolutions.net/records/483/diwakar-davar-md/a4b080ec-fb6d-49c5-8b55-676890677bd0

> FDA 483 for Diwakar Davar, M.D. on October 19, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Diwakar Davar, M.D.
- Inspection Date: 2023-10-19
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: Diwakar Davar, M.D., a Sponsor-Investigator in Pittsburgh, PA, was cited for significant deficiencies related to Institutional Review Board (IRB) oversight during clinical studies. The inspection revealed that research activities continued during a lapse in IRB approval and that changes to a study protocol were implemented without prior IRB approval. These findings indicate a failure to ensure proper ethical and regulatory review of clinical research.

## Related Officers

- [Cynthia L. Rakestraw](https://www.globalkeysolutions.net/people/cynthia-l-rakestraw/ca138abf-e5d4-43ca-b9d2-79ea6294a8c8)

Company: https://www.globalkeysolutions.net/companies/diwakar-davar-md/84f6d925-735d-4d66-87ec-92fc570fe10f

Office: https://www.globalkeysolutions.net/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8