FDA WARNING_LETTER - Baxter Healthcare Corp. - August 29, 2013

The FDA issued a Warning Letter to Baxter Healthcare Corporation following an inspection of their Round Lake, Illinois facility from July 9-29, 2013, and August 29, 2013. The inspection determined that Baxter's Class II medical devices, including HomeChoice/HomeChoice Pro APD Systems and IPUMP, were adulterated under Section 501(h) of the Act, failing to conform with current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) Regulation (21 CFR Part 820).

Key violations included: 1. **Failure to investigate complaints (21 CFR 820.198(c)):** Baxter replaced failed components on HomeChoice devices without investigating the cause and failed to assess for similar failures (e.g., 50 digital printed circuit board failures documented as "no trend"). This was a repeat observation. 2. **Inadequate corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)):** Baxter failed to initiate CAPAs for 100+ over-infusion complaints in elastomeric infusion systems and failed to follow CAPA procedures when making changes to supplier control procedures affecting ~1,000 suppliers. This was a repeat observation. 3. **Failure to ensure CAPA effectiveness (21 CFR 820.100(