483
Scott Shannon, M.D.FDA 483 - Scott Shannon, M.D. - May 27, 2022
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Record Details
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.
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ID · 102f8104-ab6e-4379-9cac-2ea934a13ca4