FDA EIR - Marc C. Gittelman, M.D. - August 26, 2021

An FDA inspection of Marc C. Gittelman, M.D., operating as South Florida Medical Research in Aventura, FL, was conducted from August 17-26, 2021. This was a high-priority, for-cause inspection focusing on a specific human drug clinical trial. The inspection, conducted under Compliance Programs 7348.003 and 7348.811, aimed to ensure compliance with regulatory requirements for clinical investigators and bioavailability/bioequivalence studies. The main violation identified, documented on a Form FDA 483, was the failure to prepare or maintain accurate case histories regarding observations and data pertinent to the investigation, specifically referencing 21 CFR 312.62(b). The core issue was inadequate documentation of laboratory sample processing. For five reviewed subjects, there was no record to confirm that critical procedures outlined in the Central Laboratory Manual were followed. These procedures included specific instructions for blood collection tube mixing, allowing samples to stand in a controlled environment for a defined duration, and maintaining appropriate temperature conditions until shipment. An internal investigation by the Contract Research Organization corroborated several deviations from these protocol-specific sample handling requirements. In response, Dr. Marc C. Gittelman acknowledged the findings on the Form FDA 483 and agreed to submit a written response detailing corrective actions within 15 business days. A verbal warning was also issued regarding the importance of adhering to all regulatory requirements.