FDA 483 - Suresh Anne, M.D. - May 19, 2023

Onyx Clinical Research in Flint, MI, a clinical investigator, was cited for two observations during an FDA inspection. The firm failed to conduct an investigation according to the signed protocol, specifically by randomizing and dosing a subject before required laboratory testing. Additionally, the firm did not maintain accurate case histories, showing discrepancies between source documentation and what was reported to the IRB for two subjects.