FDA 483 - B. Braun Medical, Inc. - August 26, 2016

B. Braun Medical, Inc. in Allentown, PA, a medical device manufacturer, was cited for two significant observations during an FDA inspection. The firm failed to submit multiple Medical Device Reports (MDRs) within 30 days for device malfunctions that could cause serious injury or death. Additionally, the company did not adequately document corrective and preventive action (CAPA) activities and results, including issues with recurring problems.