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....Read More
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