FDA 483 - Sarah D. Atkinson, M.D. - April 27, 2018

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.