# FDA 483 - Anthony J. Windebank, M.D., Clinical Investigator - September 19, 2019

Source: https://www.globalkeysolutions.net/records/483/anthony-j-windebank-md-clinical-investigator/6659db89-a62b-4675-862a-bb13678b6ab8

> FDA 483 for Anthony J. Windebank, M.D., Clinical Investigator on September 19, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Anthony J. Windebank, M.D., Clinical Investigator
- Inspection Date: 2019-09-19
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: Anthony J. Windebank, M.D., a Clinical Investigator in Rochester, MN, was cited for significant deviations from the investigational plan during an FDA inspection from September 16-19, 2019. The inspection revealed failures in following up with subjects who refused further clinic visits, leading to uncaptured adverse events, including two subject deaths. Additionally, a study coordinator improperly assessed adverse and serious adverse events, a responsibility designated solely to a physician.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/sharon-l-matson/1d2e6d91-1d00-455d-a2e6-a73b1c6b82cc)

Company: https://www.globalkeysolutions.net/companies/anthony-j-windebank-md-clinical-investigator/cc7cd312-c99b-49ae-a603-105653a303fa

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d