# FDA 483 - Sudhirkumar Patel, MD - May 17, 2012

Source: https://www.keypedia.com/records/483/sudhirkumar-patel-md/fc7931ac-6a06-49de-afdd-67b4fa5daa76

> FDA 483 for Sudhirkumar Patel, MD on May 17, 2012. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sudhirkumar Patel, MD
- Inspection Date: 2012-05-17
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Sudhirkumar Patel, MD, a clinical investigator in Greenville, SC, revealed significant deficiencies in the conduct and documentation of clinical investigations. The firm failed to adhere to investigational plans by enrolling an ineligible subject, did not adequately maintain case histories, and could not provide required investigational records due to issues with a Contract Research Organization.

## Related Officers

- [Vanessa E. Coulter](https://www.keypedia.com/people/vanessa-e-coulter/add8407c-0df8-43ed-9f5a-8063880ce638)

Company: https://www.keypedia.com/companies/sudhirkumar-patel-md/7ad80f56-46eb-483d-88e0-02520d416933

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7