FDA 483 - Steven C. Kester, M.D. - May 27, 2022

The FDA inspected Clinical Research Center of Florida & Urology Center of Florida in Pompano Beach, FL, and identified significant deficiencies in their conduct of clinical studies. The firm failed to maintain adequate and accurate case histories, evidenced by missing source documents and numerous time inconsistencies in study records. Additionally, the inspection revealed a failure to obtain proper informed consent from human subjects before performing study-related procedures.