FDA 483 - David R. Hensley, MD - August 02, 2019

The FDA inspected David R. Hensley, MD, a clinical investigator in Arlington, TX, and issued a Form 483 with two observations. The inspection revealed that the clinical investigation was not properly conducted or supervised by Dr. Hensley, with significant tasks delegated to the Director of Research. Additionally, the firm failed to maintain accurate case histories, evidenced by missing records and numerous discrepancies in signatures, initials, and dates on subject source documents and informed consent forms.