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

Source: https://www.keypedia.com/records/483/scott-a-fretzin-md/e156250b-3071-40eb-9275-5de57a82023a

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

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## Details

- Record Type: 483
- Company Name: Scott A. Fretzin, M.D.
- Inspection Date: 2025-05-01
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Scott A. Fretzin, M.D. in Indianapolis, IN, identified a failure to conduct a clinical study in accordance with good clinical practices. The inspection revealed issues with enrolling subjects who did not meet protocol-required eligibility criteria and a lack of adherence to the investigational plan, including maintaining primary source documents for washout periods. These findings indicate significant deficiencies in the oversight and execution of the clinical trial.

## Related Documents

- [483 - 2025-05-01](https://www.keypedia.com/records/483/scott-a-fretzin-md/58004c5a-a5eb-4a73-913b-2320b3c9c1d0)

## 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/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0