# FDA 483 - Mitchell Horwitz, M.D. - August 19, 2022

Source: https://www.globalkeysolutions.net/records/483/mitchell-horwitz-md/9a5a2f42-2fce-4bb6-9485-a04898567d0b

> FDA 483 for Mitchell Horwitz, M.D. on August 19, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mitchell Horwitz, M.D.
- Inspection Date: 2022-08-19
- Product Type: other
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Mitchell Horwitz, M.D., a clinical investigator in Durham, NC, revealed issues with data accuracy and record keeping. The inspection found that case histories were not accurately maintained, specifically regarding the reporting of concomitant medications in eCRFs for multiple subjects. This indicates a significant concern with the integrity of study data.

## Related Officers

- [Byungja E. Marciante](https://www.globalkeysolutions.net/people/byungja-e-marciante/5d1f2927-9017-4ab6-8ad2-521e340ef14f)

Company: https://www.globalkeysolutions.net/companies/mitchell-horwitz-md/e1c48c75-5581-4a10-b78c-11bcbc17ab53

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7