# FDA 483 - Kevin Stein, M.D. - April 23, 2025

Source: https://www.globalkeysolutions.net/records/483/kevin-stein-md/05761474-45c7-4b84-9a66-7debcb4bc798

> FDA 483 for Kevin Stein, M.D. on April 23, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kevin Stein, M.D.
- Inspection Date: 2025-04-23
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Kevin Stein, M.D. in Winston Salem, NC, identified significant deviations in the conduct of a clinical investigation. The firm failed to adhere to the investigational plan and study protocol, specifically regarding the storage temperatures of investigational product and the performance of required events for study subjects. These findings indicate serious non-compliance in clinical trial management and subject safety.

## Related Officers

- [Matthew R. Coleman](https://www.globalkeysolutions.net/people/matthew-r-coleman/6fc13ec4-a609-4c3c-961f-16cba13a3a3a)

Company: https://www.globalkeysolutions.net/companies/kevin-stein-md/31247fd3-7475-4bc3-b2cc-7dd2b6ad9ab1

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