Inci B. Yildirim, M.D.April 15, 2022

FDA 483 - Inci B. Yildirim, M.D. - April 15, 2022

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Record Details

An FDA inspection of Inci B. Yildirim, M.D. in New Haven, CT, from April 11-15, 2022, revealed significant issues with clinical trial data integrity. The firm failed to prepare and maintain accurate case histories, with numerous discrepancies identified between source documentation and the Electronic Data Capture system. These findings indicate serious concerns regarding the reliability of study data.

Company: Inci B. Yildirim, M.D.
Inspection Date: April 15, 2022
Product Type: Drugs
Office: Division of Northeast Imports
People: Kent A. Conforti (issuing_officer)
Tyanna N. Hadley (investigator)

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ID · 578aacc1-4bcd-47b4-bc27-1b90d8eeddc1