Repeated Quality Systems Issues Bring Philips Consent Decree
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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On signing a consent decree with the US FDA, Philips is halting manufacture and sales of external defibrillators produced at two facilities until the agency is satisfied the company is complying with current good manufacturing practice requirements. The suspension is expected to impact Philips' EBITA for the fourth quarter 2017 and for 2018.
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