C.R. Bard, Inc. – FDA Warning Letter, Jan 5, 2015

This FDA Warning Letter, dated July 13, 2015, addresses C.R. Bard Inc. and its Bard Peripheral Vascular facility in Tempe, AZ, and C.R. Bard Inc. facility in Queensbury, NY, following inspections from October 2014 to January 2015. The firm is a specification developer and manufacturer of Inferior Vena Cava (IVC) filter delivery systems and components, including the Denali Filter, Simon Nitinol Filter, and Recovery Cone Removal Kit.

The letter identifies significant violations:

**Adulteration/Misbranding Violations (Tempe, AZ facility):** * **Unapproved Marketing:** The Recovery Cone Removal System, Models RC-15 and FBRC, are marketed without required marketing clearance or approval (PMA or 510(k)), violating sections 501(f)(1)(B) and 502(o) of the Act. The FBRC model is marketed for specialized uses (percutaneous IVC filter removal) beyond its exempt classification. FDA requests immediate cessation of commercial distribution for these devices.

**Quality System (QS) Regulation Violations (Tempe, AZ and Queensbury, NY facilities):** * **Complaint Handling (21 CFR 820.198(a)):** Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints. This