# FDA 483 - Robert Nelson, M.D., Ph.D. - October 23, 2019

Source: https://www.globalkeysolutions.net/records/483/robert-nelson-md-phd/79d88c77-446f-4ac2-b43b-85dda35aed15

> FDA 483 for Robert Nelson, M.D., Ph.D. on October 23, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Robert Nelson, M.D., Ph.D.
- Inspection Date: 2019-10-23
- Product Type: drugs
- Office Name: Denver District Office
- Summary: Robert Nelson, M.D., Ph.D. in Phoenix, AZ, was cited for significant deficiencies in conducting a clinical investigation. The inspection revealed failures in following the investigational plan, including enrolling ineligible subjects and not reporting numerous serious adverse events. Additionally, the firm failed to obtain proper informed consent, maintain adequate case histories, and ensure proper study monitoring.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/michelle-j-hines/c8087e41-6b8a-4b9a-92ad-bba500ce6fee)

Company: https://www.globalkeysolutions.net/companies/robert-nelson-md-phd/111f3371-c3a1-4d20-8087-d8f933d01b16

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