483
Bertrand P. Cole, D.O.FDA 483 - Bertrand P. Cole, D.O. - May 16, 2025
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Record Details
An FDA inspection of Bertrand P. Cole, D.O., a clinical investigator in Portsmouth, NH, revealed a significant deviation in the conduct of a clinical study. All four subjects in the study were repeatedly overdosed with the Investigational Product, leading to adverse reactions and the interruption of their treatment. This issue stemmed from a failure to follow drug handling instructions and the protocol's titration regimen.
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ID · 15dafbe1-3b88-4bb0-bbee-1de12945179b