Maquet Cardiovascular, LLC – FDA Warning Letter, May 14, 2010

On April 13, 2010, an FDA inspection of Maquet Cardiovascular, LLC in Wayne, New Jersey, identified significant violations of the Quality System (QS) regulation (21 CFR Part 820) for their Hemashield Vascular Grafts and Fabrics. The devices were deemed adulterated and misbranded.

Key violations include: 1. **Failure to validate processes (21 CFR § 820.75(a))**: No cleaning validation was performed for the collagen impregnation process equipment, despite disinfectant efficacy testing. The firm's response was inadequate, lacking information on CAPA WAY053, investigation into other processes needing validation, and training records. 2. **Failure to revalidate processes after changes/deviations (21 CFR § 820.75(c))**: The five-year shelf life for pouch and blister tray packages was not adequately revalidated after the mechanical peel test failed acceptance criteria (five values below 0.5 lbs/in). The firm accepted the deviations without sufficient explanation or corrective actions to prevent recurrence. The response was inadequate, lacking a validation protocol or final report. 3. **Failure to report corrections/removals (21 CFR 806.10(a))**: A 2006 recall initiated by Boston Scientific (Maquet's former entity) regarding glycerol droplets in Hemashield packaging, which could prolong