FDA WARNING_LETTER - Rezai, Ali R, M.D - August 29, 2008

This FDA Warning Letter, issued to Ali R. Rezai, M.D. of Cleveland Clinic Foundation, details objectionable conditions observed during an inspection from July 22 to August 29, 2008. The inspection assessed compliance with federal regulations for clinical studies involving the (b)(4) device, where Dr. Rezai acted as both sponsor and clinical investigator.

Serious violations of 21 CFR Part 812 (Investigational Device Exemption) were identified. As sponsor, Dr. Rezai failed to submit timely progress reports to FDA and IRBs for multiple (b)(4) studies, and failed to obtain signed financial disclosure agreements from all participating investigators. As clinical investigator, violations included failure to conduct investigations according to the investigational plan (e.g., deviating from required device implantation and post-surgical assessments in (b)(4) studies, and using a different (b)(4) in the (b)(4) study), and failure to maintain accurate, complete, and current case histories, with numerous missing subject IDs, dates, and examiner initials in subject records for (b)(4) studies.

Dr. Rezai's September 2, 2008, response was deemed inadequate, lacking substantive corrective and preventive actions, and referencing irrelevant or incomplete appendices. The FDA requires a written response within fifteen working days detailing corrective actions, projected completion dates, and preventive measures to ensure future compliance. Failure to respond