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

Source: https://www.keypedia.com/records/warning_letter/harlin-stuart-md/e74fed3c-69c4-4978-9b2e-5e2ef5f5af09

> FDA WARNING_LETTER for Harlin, Stuart MD on May 21, 2010. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Harlin, Stuart MD
- Inspection Date: 2010-05-21
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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,

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Company: https://www.keypedia.com/companies/harlin-stuart-md/bfbd5942-f3f3-421b-b8cf-f8c8254e7ae7

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7