FDA WARNING_LETTER - Harlin, Stuart MD - May 21, 2010

This Warning Letter, dated July 21, 2010, informs Dr. Stuart A. Harlin of objectionable conditions observed during an FDA inspection from May 17-21, 2010, at his clinical site, Coastal Vascular & Interventional, PLLC. The inspection assessed compliance with federal regulations for the "Suprarenal Proximal Cuff Study" (IDE G990139) and "UNITE LeMaitre Vascular UniFit Aorto-Uni-iliac Stent Graft Clinical Study" (IDE (b)(4)).

Violations of 21 CFR Part 812 (Investigational Device Exemptions) and Part 50 (Protection of Human Subjects) were identified. Key violations include:

1. **Failure to conduct investigations according to the signed agreement, investigational plan, and FDA regulations [21 CFR 812.100 and 21 CFR 812.110(b)]**: Subjects (b)(4), (b)(4), and (b)(4) did not receive required CT scans at 6-month and/or 1-year follow-up visits per protocol. A serious adverse event for subject (b)(4) was reported to the sponsor beyond the required 24-hour window. Dr. Harlin's response regarding a new clinical trial section was inadequate, lacking details on staff duties,