FDA WARNING_LETTER - Carefusion 2200 Inc - November 05, 2013

The FDA conducted an inspection of CareFusion 2200, Inc. from September 9, 2013, to November 5, 2013, identifying significant violations of the Quality System (QS) Regulation (21 CFR Part 820) for medical devices, including neonatal/adult breathing circuits, oxygen masks, and biopsy needles. The devices were deemed adulterated under Section 501(h) of the Act.

Key violations include: 1. **Inadequate Corrective and Preventive Action (CAPA) Procedures (21 CFR 820.100(a)):** CareFusion failed to adequately investigate complaints of debris/particulate matter in Denver Ascites Shunts, specifically CAPA IS-MN-317, which did not analyze the foreign material. 2. **Failure to Investigate Complaints (21 CFR 820.198(c)):** Thirty-two complaints regarding particulate matter in Denver Ascites Shunts since August 2011 were inadequately investigated. Ten reviewed complaints referenced a "previous complaint" and corrective actions that could not be located or verified. 3. **Inadequate Supplier Evaluation (21 CFR 820.50(a)(1)):** Supplier Self Audit Questionnaires for Level I suppliers were approved despite incomplete quality system questions, and responses like "Confidential" were accepted without follow-up