FDA 483 - Sharleen St. Surin-Lord, M.D. - January 31, 2023

An FDA inspection of Sharleen St. Surin-Lord, M.D. in Largo, MD, revealed significant deficiencies in the conduct of clinical investigations. The firm failed to adhere to investigational plans and protocols, leading to issues such as subjects not meeting inclusion criteria, incomplete study activities, and improper administration of investigational products. Additionally, the inspection found a failure to accurately prepare and maintain case histories, with discrepancies in reporting adverse events and concomitant medications between source documents and the Electronic Data Capture system.