FDA WARNING_LETTER - Cardinal Health 414 LLC - April 15, 2008

An FDA inspection of Cardinal Health 414 LLC in Dublin, OH, from April 10-15, 2008, determined that their Secure Safety Insert System, a point-of-use sharps container, is a medical device. The inspection revealed the devices are adulterated under section 501(h) of the Act due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820). The firm's April 22, 2008 response to the Form FDA 483 was deemed inadequate as many proposed corrective actions were still in development. Violations included failure to establish adequate management controls for an effective quality system (21 CFR 820.20), conduct quality audits (21 CFR 820.22), establish corrective and preventive action procedures (21 CFR 820.100), establish complaint handling procedures (21 CFR 820.198(a)), establish procedures for acceptance of incoming product (21 CFR 820.80(b)), and establish design change control procedures (21 CFR 820.30(i)). Additionally, the devices were misbranded under section 502(t)(2) for failure to develop written Medical Device Reporting procedures (21 CFR 803.17). The FDA requires prompt corrective action to prevent regulatory measures such as seizure, injunction, civil money penalties, and impacts on federal contracts, premarket applications, and Certificates to Foreign Governments. Cardinal Health must notify the FDA within fifteen working days of specific corrective steps, including documentation and a timetable for completion.