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Compliance Quality Control Medical Device

Repeated Quality Systems Issues Bring Philips Consent Decree

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Executive Summary

After two warning letters, eight inspections, and quality systems concerns dating to 2009, the government has largely blocked Philips Healthcare from manufacturing automated external defibrillators and similar products made at two of the company's facilities until the concerns are resolved.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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