LeMaitre Vascular – FDA Warning Letter, Feb 5, 2008

On June 3, 2008, the FDA issued a Warning Letter to LeMaitre Vascular, Inc. following an inspection from January 15 to February 5, 2008. The inspection assessed compliance with federal regulations for the clinical study of the (b)(4) device.

The FDA identified serious violations of 21 CFR Part 812 – Investigational Device Exemptions. Key deficiencies included:

1. **Failure to secure investigator compliance (21 CFR 812.46(a)):** LeMaitre Vascular failed to ensure investigators adhered to agreements and the investigational plan, resulting in incomplete case report forms (CRFs) for the Feasibility Study and lack of documentation for corrections/clarifications. Examples include incomplete aneurysm and device status assessments and CT scans not performed per protocol. The company's response, detailing new investigator agreements and financial incentives, was deemed incomplete as it lacked a plan for submitting updated Phase I data to IRBs and the FDA, and a plan for securing ongoing investigator compliance. 2. **Failure to ensure adequate monitoring (21 CFR 812.40):** LeMaitre Vascular did not monitor investigations according to its SOP, which required annual monitoring. Despite acquiring assets in (b)(4), monitoring visits didn't begin until February (b)(4) and were not continued yearly. The company's response, acknowledging past insufficient data management and detailing