FDA WARNING_LETTER - Baxter Healthcare Corporation

An FDA inspection of Baxter Healthcare Corporation's Irvine, California facility (December 2012 - June 2013) found its elastomeric infusion pumps and specialty medical devices adulterated, non-compliant with the Quality System regulation (21 CFR Part 820). This indicated systemic manufacturing and quality control deficiencies. Key violations included inadequate procedures for corrective and preventive actions (21 CFR § 820.100(a)), design output (21 CFR § 820.30(d)), and nonconforming product control (21 CFR § 820.90(a)). The firm also failed to record changes (21 CFR § 820.40(b)), establish acceptance activity procedures (21 CFR § 820.80(a)), and properly validate processes (21 CFR § 820.75(e)) and software (21 CFR § 820.70(i)). Supplier requirements were not established (21 CFR § 820.50(a)), document control was deficient (21 CFR § 820.40), equipment calibration was inadequate (21 CFR § 820.72(a)), and device history records did not conform to master records (21 CFR § 820.184). Baxter's responses were inadequate, often promising re-engineered systems without specific details. The FDA requires prompt, comprehensive corrective action, with a detailed written response within fifteen business days outlining steps, prevention plans, and a timetable. Failure to comply could lead to severe regulatory actions, including seizure, injunctions, civil penalties, and impact on federal contracts and device approvals.