FDA 483 - Johnnie M. Woodson, MD - February 02, 2022

An FDA inspection of Johnnie M. Woodson, MD, a clinical investigator in Henderson, NV, revealed significant deviations from a clinical investigation protocol. The investigation was not conducted in accordance with the signed statement of investigator, with issues including improper subject enrollment, incomplete follow-up visits, incorrect vital sign measurement procedures, unadministered investigational product, and delayed shipping of blood samples. These findings indicate a serious lack of adherence to the study protocol and regulatory requirements for clinical trials.