FDA WARNING_LETTER - Edwards Lifesciences, LLC - February 22, 2013

This FDA Warning Letter, Ref: DEN-13-14-WL, issued to Edwards Lifesciences, LLC, on May 22, 2013, details violations of the Quality System regulation (21 CFR Part 820) observed during an inspection from January 22 to February 22, 2013, at their Draper, UT facility. The firm manufactures cardiovascular surgical devices, including QuickDraw Venous Cannulae and components of the Sapien Transcatheter Heart Valve System.

Key violations include: 1. **Failure to validate processes (21 CFR 820.75(a)):** Specifically, the (b)(4) process for QuickDraw Venous Cannulae was not validated, leading to device breakages and requiring secondary surgeries. Packaging validation for sterile barrier pouches was incomplete per ISO 11607-1-2006. 2. **Inadequate corrective and preventive actions (CAPA) (21 CFR 820.100(a)):** The firm failed to investigate and implement effective CAPAs for recurring QuickDraw Cannulae breakages, EndoClamp occlusion difficulties (despite multiple complaints and a redesigned device), and persistent issues with finished product pouch seals (e.g., "hazy" seals, embedded particulates). Investigations into particulate contamination sources were also inadequate. 3. **Failure in design validation (21 CFR