B. Braun Medical, Inc.
Product DetailsProcedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
Specifically, your firm's Product Complaints Work Instruction, doc #SOP-MDC-3000011, effective 6/18/2009, rev 3.0, describes the complaint handling procedure for your Carrollton location and references your corporate level procedure, Complaint Management System, doc #SOP-MD-2011588, effective 9/30/2009, rev 4.0 (and the previous rev 3.0, effective 4/7/2009). All these governing procedures reference a goal of completion time frame for complaints. For example, your complaints are not always being closed in a timely manner.