FDA WARNING_LETTER - Scully, Sean M.D. - April 15, 2010

This Warning Letter, dated July 30, 2010, was issued to Dr. Sean Scully of the University of Miami Hospital following an FDA inspection from March 15 to April 15, 2010. The inspection assessed compliance with federal regulations for the "ReCap? Total Resurfacing System" Investigational Device Exemption (IDE) study.

Violations of 21 CFR Part 812 (Investigational Device Exemptions) were identified. Dr. Scully failed to conduct the investigation according to the signed agreement, investigational plan, applicable FDA regulations, and IRB/FDA conditions [21 CFR 812.100 and 812.110(b)]. Specifically, adverse events for four subjects were not recorded on AE forms or reported to the sponsor and IRB as required. Additionally, "Lost to Follow-Up" forms were not completed for two subjects, and no attempts to contact them were documented.

Furthermore, Dr. Scully failed to maintain accurate, complete, and current records of each subject's case history and a complete and current protocol [21 CFR 812.140(a)(3) and 812.140(a)(4)]. Examples include incomplete Harris Hip Score CRFs for two subjects, missing medication details in one subject's history, and the absence of the current study protocol version at the site prior to inspection