Unreported MDRs, Corrective Actions Lead to Form 483 for B. Braun

Multiple failures to report adverse events and corrective actions to the FDA were cited in a six-observation Form 483 issued to B. Braun Medical at the conclusion of a June 25 to Aug. 16 inspection of its Carrollton, Texas, facility. In 2009 and 2010, the company failed to inform the agency about nine corrections made to infusion pumps to ensure the drug library software would not be lost, the Form 483 states. And B. Braun did not notify the FDA about an ongoing correction launched in October 2011 involving replacement of the hold button circuit on failed infusion pumps.
The GMP Letter