Atrium Medical Corporation – FDA Warning Letter, Sep 7, 2012

On October 11, 2012, the FDA issued a Warning Letter to Atrium Medical Corporation following an inspection from July 31 to September 7, 2012. The inspection revealed that Atrium's medical devices, including C-QUR mesh, V12 and iCast Covered Stents, and Express Pre-Filled Chest Drains, were adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act. This was due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. **Failure to validate the Ethylene Oxide (ETO) sterilization process (21 CFR 820.75(a))**: The firm could not demonstrate that the single process challenge device (PCD) used was representative of all 39 devices across six product families. Documentation for the PCD model and lot number was also missing. Atrium's response was inadequate, requiring documentation of successful re-validation and a plan to prevent recurrence. 2. **Failure to investigate complaints involving device failure (21 CFR 820.198(c))**: Four complaints related to C-QUR mesh infections were closed without obtaining sample culture results or further investigation. The complaint procedure lacked instructions for collecting detailed information, leading to missing