# FDA 483 - Michael J. Schurr, MD - September 14, 2020

Source: https://www.globalkeysolutions.net/records/483/michael-j-schurr-md/7b4b23f7-dec7-4a94-ae72-d5c80e062630

> FDA 483 for Michael J. Schurr, MD on September 14, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Michael J. Schurr, MD
- Inspection Date: 2020-09-14
- Product Type: drugs
- Office Name: Denver District Office
- Summary: Michael J. Schurr, MD, a clinical investigator in Aurora, CO, received a Form 483 citing two significant observations. The firm failed to promptly report a serious adverse event (SAE) to the medical monitor as per protocol. Additionally, the principal investigator did not provide adequate oversight, leading to unqualified study personnel performing critical study assessments.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/courtney-r-bratina/3ad4bfd5-d0da-4801-8e90-a5a3ba9291c3)
- [issuing_officer](https://www.globalkeysolutions.net/people/ruth-a-williams/f6dd5e30-fe9a-4b18-9703-dc471a55f24f)

Company: https://www.globalkeysolutions.net/companies/michael-j-schurr-md/6f6cad69-720b-403b-a956-fad8a8b4adfc

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face