FDA WARNING_LETTER - baxter healthcare sa/ - May 12, 2014

An FDA inspection from March to May 2014 at Baxter Healthcare of Puerto Rico, a manufacturer of sterile IV sets and parental bags, found its devices adulterated under 21 U.S.C. § 351(h) due to non-compliance with the Quality System Regulation (21 C.F.R. Part 820). The firm's response dated June 3, 2014, was deemed inadequate for several violations. Key violations include: 1) Failure to control production processes to ensure device conformity (21 CFR 820.70(a)). The firm's visual inspection for particulate matter in nutritional containers and empty solution bags was not validated, and employee certification was insufficient. This led to confirmed particulate matter in returned products despite 100% visual inspections. 2) Failure to properly implement CAPA procedures (21 C.F.R. § 820.100(a)). A CAPA investigation into particulate matter complaints was inadequate, untimely, and ineffective, failing to identify the root cause or address the non-validated visual inspections. A 2010 medical assessment indicated a potential for death or serious injury, yet immediate action was not taken, and a field corrective action was improperly dismissed based on inaccurate data and reliance on user detection. Baxter is implementing corrective actions, including using consultants for CAPAs, with some expected by October 2014. However, the firm must address the handling of previously distributed potentially defective products, conduct retrospective assessments, and provide updates on CAPA reviews and a separate "leak defect" investigation. Failure to promptly correct these violations could lead to regulatory actions, impact federal contracts, and hinder device approvals or export certificates. A written response detailing corrective actions and timelines is required within 15 working days.