FDA WARNING_LETTER - Katzen, Barry M.D. - October 17, 2007

The FDA conducted an inspection at Baptist Cardiac and Vascular Institute from October 15-17, 2007, concerning the clinical study [redacted], involving a medical device. The inspection aimed to ensure compliance with federal regulations, specifically 21 CFR Part 812 (Investigational Device Exemptions), and to protect human subjects. The review revealed serious and repeated violations. The identified deficiencies include: 1) Failure to conduct the investigation according to the signed agreement, investigational plan, and applicable FDA regulations (21 CFR 812.100 and 812.110(b)), specifically by not performing required follow-up examinations and diagnostic tests. 2) Failure to obtain prior approval from the sponsor, FDA, and the reviewing IRB for changes or deviations from the investigational plan that could affect subject rights, safety, or welfare in non-emergency situations (21 CFR 812.150(a)(4)). 3) Failure to maintain accurate, complete, and current records of each subject's case history and device exposure (21 CFR 812.140(a)(3)), with noted discrepancies in diagnostic test reports, progress reports, and CRFs. Notably, a previous FDA inspection in 2003 resulted in an Untitled Letter citing similar deviations, indicating that prior corrective actions were ineffective. The FDA emphasized the investigator's responsibility to comply with regulations, regardless of sponsor responsibilities. The Institute is required to submit written documentation within fifteen working days detailing corrective actions, including policies, procedures, and training plans to ensure future compliance with investigational plans, proper deviation approvals, and accurate record-keeping, along with a plan to correct current case histories and an updated comprehensive corrective action plan.