B. Braun Medical, Inc. - October 8, 2010
Issue Date
Oct 08, 2010
Region
Southwest
Category
Device
$117.00
Address 1
1601 Wallace Dr.
Address 2
Suite 150
City
Carrollton
State
TX
Zip/Postal Code
75006-6690
Country
US
Inspection Range
Sep 14, 2010 - Oct 08, 2010
Pages
5
First Observation
Procedures 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.
Investigator(s): Lauren E. SkokanSpecifically, 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.