# FDA 483 - James R. Corbett, M.D. - July 08, 2019

Source: https://www.keypedia.com/records/483/james-r-corbett-md/e76497ab-8fe8-4dd8-8241-e99f55dc97df

> FDA 483 for James R. Corbett, M.D. on July 08, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: James R. Corbett, M.D.
- Inspection Date: 2019-07-08
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: James R. Corbett, M.D. in Ann Arbor, MI, was inspected regarding their role as a Sponsor-Investigator. The inspection revealed significant deficiencies in informed consent, study monitoring, IRB oversight, case history maintenance, and investigational drug accountability. These issues indicate a severe lack of adherence to regulatory requirements for clinical investigations, including continuing to enroll subjects after IND termination.

## Related Documents

- [WARNING_LETTER - 2019-07-08](https://www.keypedia.com/records/warning_letter/james-r-corbett-md/b12e4ea3-325b-4ad3-af76-130998304710)

## Related Officers

- [Andrace Deyampert](https://www.keypedia.com/people/andrace-deyampert/cdb4f833-488b-42b9-abab-4216435bce4c)

Company: https://www.keypedia.com/companies/james-r-corbett-md/f7cef1cf-f57a-46ce-a220-bb1fe875127e

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