# FDA 483 - Scott Shannon, M.D. - May 27, 2022

Source: https://www.keypedia.com/records/483/scott-shannon-md/102f8104-ab6e-4379-9cac-2ea934a13ca4

> FDA 483 for Scott Shannon, M.D. on May 27, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Scott Shannon, M.D.
- Inspection Date: 2022-05-27
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of Scott Shannon, M.D. in Fort Collins, CO, a clinical investigator, revealed a significant issue regarding the conduct of an investigation. The firm failed to ensure that the site physician determined the severity of Adverse Events as required by the protocol. This resulted in 59 adverse event entries lacking proper physician review and signature.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/courtney-r-bratina/3ad4bfd5-d0da-4801-8e90-a5a3ba9291c3)

Company: https://www.keypedia.com/companies/scott-shannon-md/4bf58576-61a4-4797-b48e-d6836f0a03c0

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