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

Source: https://www.keypedia.com/records/483/inci-b-yildirim-md/578aacc1-4bcd-47b4-bc27-1b90d8eeddc1

> FDA 483 for Inci B. Yildirim, M.D. on April 15, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Inci B. Yildirim, M.D.
- Inspection Date: 2022-04-15
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: 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.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/kent-a-conforti/8d3d3e82-cd97-420e-8840-df92d6eeba09)
- [investigator](https://www.keypedia.com/people/tyanna-n-hadley/8fdebfd7-d6f3-44ab-9dcb-864ab6d55d53)

Company: https://www.keypedia.com/companies/inci-b-yildirim-md/2fdd777c-9888-4116-a0fc-4c363a16fb19

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94