FDA WARNING_LETTER - Zimmermann, Ralf C. - June 25, 2013

This Warning Letter addresses objectionable conditions observed during an FDA inspection at Columbia University Medical Center (CUMC) between June 5 and 25, 2013, concerning two clinical investigations of investigational drug (b)(4). The inspection, part of the Bioresearch Monitoring Program, revealed that Dr. Ralf Zimmerman failed to adhere to statutory requirements and FDA regulations, compromising subject rights, safety, welfare, and data integrity. Key violations include failure to personally conduct or supervise clinical investigations (21 CFR 312.60), leading to inadequate oversight of delegated tasks. Specifically, Dr. Zimmerman failed to obtain legally effective informed consent from 28 subjects and administered investigational drug to 10 subjects before obtaining consent (21 CFR 312.60 and 21 CFR 50.20). Additionally, the investigation was not conducted according to the investigational plan (21 CFR 312.60), with four subjects receiving incorrect dosing. Finally, Dr. Zimmerman failed to assure continuous IRB review and approval (21 CFR 312.66), enrolling six subjects during a lapse in IRB approval. While Dr. Zimmerman acknowledged these failures and CUMC implemented corrective actions, the FDA deemed his personal response inadequate, lacking sufficient detail on how he will prevent future violations. The FDA requires a written response within fifteen working days detailing corrective actions, warning that failure to comply may result in further regulatory action.