FDA WARNING_LETTER - u s infusion, inc. - September 17, 2014

An FDA inspection of US Infusion, Inc. dba Trucare Biomedix-USA in September 2014 revealed significant violations of the Quality System regulation (21 CFR Part 820) for their Class II IV administration sets, deeming them adulterated. The firm also imports Class I IV poles and Class II syringes.

Key violations include: 1. **Purchasing Controls (21 CFR 820.50):** Failure to establish adequate procedures to ensure purchased products and services conform to requirements, including supplier quality control, personnel qualification, process validation, and equipment maintenance. The firm's procedures did not require obtaining essential documentation from future suppliers, and there was uncertainty regarding sterilization methods. Discrepancies were noted between website claims of quarterly supplier audits and actual practice. 2. **Quality Audits (21 CFR 820.22):** Failure to establish procedures for and conduct quality audits, lacking a documented schedule, specific criteria, and completed internal audits. 3. **Corrective and Preventive Action (CAPA) (21 CFR 820.100(a)):** CAPA procedures were inadequate, lacking requirements for verification/validation of effectiveness, definitions of preventive actions, and the use of statistical methodology for recurring problems. 4. **CAPA Documentation (21 CFR 820.100(b)):** Inadequate documentation of CAPA