# FDA 483 - Pratik Doshi, M.D. - March 07, 2025

Source: https://www.globalkeysolutions.net/records/483/pratik-doshi-md/eb8a9a18-cb03-497a-8f74-e22c611a80a5

> FDA 483 for Pratik Doshi, M.D. on March 07, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pratik Doshi, M.D.
- Inspection Date: 2025-03-07
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Pratik Doshi, M.D., a bioequivalence clinical testing facility in Vadodara, Gujarat, India, identified one observation. The firm failed to meet general requirements for informed consent. Specifically, consent forms for a clinical research project included a statement that the study was "not of an experimental nature," which did not minimize the possibility of coercion or undue influence.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/lori-gioia/34b9339b-0bd2-4e41-8da1-b445ad829e53)

Company: https://www.globalkeysolutions.net/companies/pratik-doshi-md/568e311c-84d8-45aa-aa5c-95515e4195d2

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8