FDA 483 - Graphic Controls Acquisition Corporation - February 23, 2021

Graphic Controls Acquisition Corporation, a medical device manufacturer in Buffalo, NY, was cited for four observations during an FDA inspection. The inspection revealed significant deficiencies in supplier controls for AED defibrillator pads, failure to report serious adverse events via MDRs, inadequate management review procedures, and insufficient verification/validation within their CAPA system. These issues indicate a moderate level of non-compliance with quality system regulations, particularly concerning device safety and quality oversight.