483
Sarah D. Atkinson, M.D.Sarah D. Atkinson, M.D. – FDA 483, Apr 27, 2018
Record Details
An FDA inspection of Sarah D. Atkinson, M.D., a clinical investigator in Rochester, NY, revealed significant issues with the conduct of clinical investigations and the maintenance of accurate records. Observations included a failure to follow the investigational plan, specifically regarding the lack of source data to verify subject eligibility, and a failure to maintain accurate case histories due to undocumented data alterations.
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ID · 8499f73f-7008-4176-a49e-3f3ba5f6c1f4
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