FDA 483 - Michael A. Shiekh, M.D. - May 07, 2019

Michael Shiekh, M.D., a clinical investigator in Dallas, TX, was cited for two observations during an FDA inspection. The firm failed to conduct an investigation in accordance with the investigational plan, specifically regarding adverse event reporting and adherence to study procedures. Additionally, the firm did not prepare or maintain adequate and accurate case histories, leading to numerous discrepancies and inconsistencies in source data.