With regard to FDA-483 Item 4, Braun was cited for not reporting two MDR reportable complaints, Mfr reports #1641965-1998-00018/24, to FDA within the 30 days time frame. Your response indicated that Braun is currently changing the complaint handling system from tracking complaint information on an _____ spreadsheet to using an off-the-shelf database system, _____ tracker. As required by 21 CFR 820.70(i), Automated Processes, this off-the-shelf software shall be validated for its intended use if Braun has not already done so.
