FDA WARNING_LETTER - White, Rodney A., M.D. - June 13, 2008

The FDA issued a Warning Letter to Rodney A. White, M.D., Chief Vascular Surgery at Harbor-UCLA Medical Center, following an inspection from May 21 to June 13, 2008. The inspection assessed compliance with federal regulations for clinical studies using the [(b)(4)] device.

The inspection revealed serious violations of 21 C.F.R. Part 812 – Investigational Device Exemption. Key violations include:

1. **Failure to conduct the investigation according to the signed agreement, investigational plan, and applicable FDA regulations (21 CFR 812.150(a)(4), 21 CFR 812.100, and 21 CFR 812.110(b))**: Dr. White enrolled subjects who met exclusion criteria without obtaining prior approval from the sponsor, IRB, or FDA for these protocol deviations. Specific examples cited include subjects violating Exclusion Criteria E. and P.

2. **Failure to prepare and submit complete, accurate, and timely reports of unanticipated adverse device effects (21 CFR 812.150(a)(1))**: Dr. White failed to report unanticipated adverse device effects to the reviewing IRB and sponsor within 10 working days of learning of the effect. Specific subject numbers and event dates were provided, showing delays in reporting.

Dr. White is required to provide written documentation