# FDA 483 - John J. Wrenn, M.D. - April 15, 2024

Source: https://www.keypedia.com/records/483/john-j-wrenn-md/21a6e928-c108-4cbc-9054-cdc6626456d3

> FDA 483 for John J. Wrenn, M.D. on April 15, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: John J. Wrenn, M.D.
- Inspection Date: 2024-04-15
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: John J. Wrenn, M.D., a clinical investigator in Greensboro, NC, was cited with two observations during an FDA inspection. The inspection revealed a lack of proper oversight over clinical research studies, specifically regarding investigational product accountability and the provision of regulatory documents. Additionally, investigational drug disposition records were found to be inadequate, with missing or incomplete subject accountability logs.

## Related Officers

- [investigator](https://www.keypedia.com/people/anthony-j-grace/023993d4-63ef-40ba-a538-42479b65011c)

Company: https://www.keypedia.com/companies/john-j-wrenn-md/dd777938-8de5-43ac-a31c-74615d14a5b8

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