# FDA 483 - Vijay M. Patel, M.D. - February 04, 2022

Source: https://www.keypedia.com/records/483/vijay-m-patel-md/b706b69c-a9bd-4a1f-a5bd-98aec02a3232

> FDA 483 for Vijay M. Patel, M.D. on February 04, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vijay M. Patel, M.D.
- Inspection Date: 2022-02-04
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Vijay M. Patel, M.D., a clinical investigator, revealed significant deficiencies in the conduct of an investigational product study. The firm failed to maintain adequate records for dose preparation, did not conduct the investigation according to the signed plan, and exhibited a severe lack of oversight, leading to dosing errors and enrollment of ineligible subjects across multiple sites. Additionally, the firm failed to promptly report unanticipated problems and protocol deviations to the IRB.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/latrice-g-jones/308e84ec-6e35-425d-8b24-e7f6c5391db5)

Company: https://www.keypedia.com/companies/vijay-m-patel-md/9bbb217b-5ede-4d0b-af13-8901b4c2beb0

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6