FDA EIR - Biosense Webster, Inc. - September 27, 2016

An FDA inspection of Biosense Webster, Inc. in Irwindale, CA, a Class II and III medical device manufacturer, was conducted from September 21-27, 2016. This pre-announced inspection, part of a FY16 Risk-Based Work Plan focusing on catheters with coating, followed Compliance Program 7382.845 for Medical Device Manufacturers. The inspection employed a Level II Quality System Inspection Technique (QSIT), reviewing Management Controls, Production and Process Controls, Purchasing Controls, Corrective and Preventative Action (CAPA), and Design Controls. No formal violations were identified, and no FDA Form 483 was issued to the firm. However, the inspection concluded with two discussion items for management. Firstly, it was noted that complaint files required more complete documentation, specifically regarding the number of attempts to obtain lot numbers and the inclusion of physician names for certain complaints. Secondly, aeration chart recordings within sterilization records were not clearly visible. In response, management committed to incorporating improved documentation practices into the complaint handling process and ensuring future aeration copies in sterilization records are colored for better visibility. The company manufactures cardiac ablation and diagnostic catheters, with some products like the Preface Guiding Sheath being contract manufactured, while others like NogaStar catheters are produced on-site.