# FDA 483 - Suresh Anne, M.D. - May 19, 2023

Source: https://www.globalkeysolutions.net/records/483/suresh-anne-md/835ef1c5-7a38-4bca-a031-10893a2b967f

> FDA 483 for Suresh Anne, M.D. on May 19, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Suresh Anne, M.D.
- Inspection Date: 2023-05-19
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Onyx Clinical Research in Flint, MI, a clinical investigator, was cited for two observations during an FDA inspection. The firm failed to conduct an investigation according to the signed protocol, specifically by randomizing and dosing a subject before required laboratory testing. Additionally, the firm did not maintain accurate case histories, showing discrepancies between source documentation and what was reported to the IRB for two subjects.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/dina-a-tallman/e9bf2b98-6697-4d7c-9052-84339536acfd)

Company: https://www.globalkeysolutions.net/companies/suresh-anne-md/224b7a49-5956-463a-85ec-097c5b1d8fac

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0