483
Medtronic NeuromodulationFDA 483 - Medtronic Neuromodulation - January 21, 2011
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An FDA inspection of Medtronic Neuromodulation in Minneapolis, MN, revealed significant deficiencies in quality system processes. The firm failed to adequately validate manufacturing processes and product designs, and exhibited severe issues with complaint handling and corrective and preventive action documentation. These observations indicate a systemic breakdown in ensuring product quality and safety.
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ID · f21b8cb5-3478-4780-aec4-4e5833994a7e