FDA WARNING_LETTER - Baxter Healthcare Corporation - December 14, 2009

The FDA issued a Warning Letter to Baxter Healthcare Corporation, Renal Division, following a November-December 2009 inspection, citing significant deviations from medical device regulations. The firm's HomeChoice peritoneal dialysis systems, MiniCaps, and transfer sets were deemed misbranded due to failures in Medical Device Reporting (MDR) under 21 CFR Part 803. Violations included inadequate internal systems for identifying and evaluating MDR events (21 CFR 803.17), failure to submit timely reports for deaths/serious injuries (21 CFR 803.50(a)(1)) and device malfunctions likely to cause serious harm (21 CFR 803.50(a)(2)). Additionally, the inspection revealed Quality System regulation deficiencies (21 CFR Part 820), such as inadequate procedures for corrective and preventive actions (CAPA) regarding nonconforming products and verifying CAPA effectiveness (21 CFR 820.100(a)(3), (a)(4)). Complaint handling procedures were found to be inconsistent (21 CFR 820.198(a)(1)), and procedures for controlling manufacturing materials to prevent adverse effects on device quality were lacking (21 CFR 820.70(h)). The firm's responses to the FDA 483 observations were largely inadequate. Baxter must promptly correct these violations within 15 working days, providing a detailed plan and documentation. Non-compliance may result in regulatory actions, including seizure, injunction, civil penalties, and impact product approvals and international trade.