# FDA 483 - Scott A. Fretzin, M.D. - May 01, 2025

Source: https://www.keypedia.com/records/483/scott-a-fretzin-md/58004c5a-a5eb-4a73-913b-2320b3c9c1d0

> FDA 483 for Scott A. Fretzin, M.D. on May 01, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Scott A. Fretzin, M.D.
- Inspection Date: 2025-05-01
- Product Type: drugs
- Office Name: Detroit District Office
- Summary: An FDA inspection of Scott A. Fretzin, M.D., a clinical investigator in Indianapolis, revealed a failure to conduct a clinical study in accordance with good clinical practices. The inspection found issues with enrolling subjects who did not meet protocol-required eligibility criteria and not adhering to the investigational plan regarding primary source documents and prohibited medication instructions. These findings indicate significant deviations in the conduct of the clinical trial.

## Related Documents

- [483 - 2025-05-01](https://www.keypedia.com/records/483/scott-a-fretzin-md/e156250b-3071-40eb-9275-5de57a82023a)

## Related Officers

- [investigator](https://www.keypedia.com/people/chelsea-w-lamm/d7a8dd67-dc26-4c8a-8e3c-aebc267cb775)
- [investigator](https://www.keypedia.com/people/dina-a-tallman/e9bf2b98-6697-4d7c-9052-84339536acfd)

Company: https://www.keypedia.com/companies/scott-a-fretzin-md/f3245efc-0c0b-4d99-8e68-dba50b92ea0a

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03