The QMN Weekly Bulletin
Quality / Medical Devices

Maquet 483 Details Repeat Issues With CAPAs, MDR Handling

April 4, 2014
Maquet Cardiovascular received a Form 483 with 17 observations, including several repeat observations related to complaint reporting, process validation, CAPAs and other issues. For example, some actions and action plans that should have been documented as CAPAs were not, according to the Oct. 16 form.
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