# FDA 483 - Blair M. Brengle, M.D. - July 08, 2021

Source: https://www.globalkeysolutions.net/records/483/blair-m-brengle-md/94dde43e-1ad1-48e8-9bf4-1e90f497f761

> FDA 483 for Blair M. Brengle, M.D. on July 08, 2021. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Blair M. Brengle, M.D.
- Inspection Date: 2021-07-08
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Blair M. Brengle, M.D., a clinical investigator in Indianapolis, IN, was cited for significant deficiencies in clinical trial conduct. The inspection revealed failures in maintaining accurate case histories, including issues with subject eligibility, documentation, and data integrity. Additionally, the firm failed to report Serious Adverse Events in a timely manner and conducted study procedures on subjects before obtaining proper informed consent.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/dina-a-tallman/e9bf2b98-6697-4d7c-9052-84339536acfd)
- [U.S. Food and Drug Administration](https://www.globalkeysolutions.net/people/myra-k-casey/a2fae714-2ba3-4c60-9f54-990fc7b169c9)

Company: https://www.globalkeysolutions.net/companies/blair-m-brengle-md/20e818ec-0aec-4e25-87ac-4e6e195a9bd4

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0