483
Philip M. Bolton, M.D.Philip M. Bolton, M.D. – FDA 483, Jul 23, 2020
Record Details
Philip M. Bolton, M.D., a clinical investigator, was cited for significant deficiencies during a human clinical study involving an investigational new drug. The inspection revealed failures to adhere to the study protocol, specifically regarding subject exclusion criteria and the use of prohibited medications. Additionally, the firm failed to maintain adequate and accurate case histories for study subjects.
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ID · eb4ba6ca-1eb7-4213-bc65-84f9ff54ce04
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