FDA 483 - Scott A. Fretzin, M.D. - May 01, 2025
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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.
ID · 58004c5a-a5eb-4a73-913b-2320b3c9c1d0