483
Wayne M. Clark, MDWayne M. Clark, MD – FDA 483, Oct 27, 2023
Record Details
An FDA inspection of Wayne M. Clark, MD, Clinical Investigator in Portland, OR, revealed two significant observations. The inspection found that the clinical investigation was not conducted according to the investigational plan and applicable FDA regulations, specifically regarding the blinding of study team members. Additionally, records of subject case histories were found to be inaccurate, impacting data integrity.
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