Consent Decree

The Consent Decree will remain in effect for a minimum of five years following the lifting of the injunction. After five years, if Philips has been in continuous compliance with FDA’s laws and regulations for that period, Philips may petition the United States District Court that had entered the order to vacate the injunction. During this five-year period, FDA may inspect at its sole discretion.  At least once a year, Philips is required to have a third-party auditor inspect the ECR facilities covered by the decree and submit their reports to both FDA and Philips.