FDA 483 - William C. Biggs, M.D. - July 12, 2019

William C. Biggs, M.D., a clinical investigator in Amarillo, TX, was cited for two significant issues during an FDA inspection. The firm failed to conduct an investigation in accordance with its investigational plan, specifically regarding the accurate reporting of values for study subjects. Additionally, the firm did not prepare or maintain adequate and accurate case histories, failing to document pertinent observations and data in electronic case report forms as required by the protocol.