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# Philips Consent Decree Posted
- URL: https://www.fdaweb.com/philips-consent-decree-posted/
- Published: 2017-11-02T12:00:00.000Z
- Updated: 2026-09-14T22:59:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140034

***FDA Webview*** has posted the court-approved [consent decree](http://www.fdaweb.com/download.php?file=ECF%5FNo.%5F10%5FConsent%5FDecree%5Ffor%5FPI.pdf) between FDA and Philips North America that prohibits manufacturing, processing, packing, holding, or distributing medical devices made by the firm’s Emergency Care and Resuscitation business unit at facilities in Andover, MA, and Bothell, WA, until they comply with agency regulations ([see earlier story](https://www.fdaweb.com/fda-gets-injunction-against-philips-defibrillators/)). The government’s complaint said the firm was responsible for the manufacture and distribution of adulterated devices because its automatic external defibrillators and Q-CPR meters were manufactured in violation of current good manufacturing practice requirements under the Quality System Regulation. It said the company failed to establish and maintain adequate processes regarding its corrective and preventive action procedures, design verification and validation controls, and product specifications.