FDA WARNING_LETTER - Chawla, Sant P., M.D. - August 27, 2009

An FDA inspection conducted between August 5 and 27, 2009, at Sarcoma Oncology Center, led by Dr. Sant P. Chawla, revealed significant non-adherence to FDA regulations governing clinical investigations for Protocols (b)(4) and (b)(4). The inspection, part of the Bioresearch Monitoring Program, identified two primary violations. First, Dr. Chawla failed to conduct studies according to investigational plans (21 CFR 312.60). This included a subject receiving an overdose due to a miscalculated drug dosage and multiple instances of pharmacokinetic (PK) samples being collected at incorrect time intervals (after infusion completion instead of initiation), undermining data reliability. Second, the center failed to maintain adequate and accurate case histories (21 CFR 312.62(b)), with numerous adverse events documented in progress notes but not timely reported on electronic case report forms, some with delays up to 15 months, potentially jeopardizing subject safety. While corrective actions for dosing errors and CRF completion were deemed acceptable if implemented, the FDA expressed concern regarding the adequacy of the response for PK sampling errors, noting a fundamental misunderstanding of the protocol. The letter requires a written response within 15 working days detailing actions to prevent future violations, warning of potential regulatory action.