Consent Decree

The government sought a Consent Decree from Philips due to issues raised by regulators primarily concerning Emergency Care & Resuscitation (ECR) manufacturing practices at our Andover, Massachusetts and Bothell, Washington sites. The Decree includes provisions covering other Patient Care & Monitoring Solutions (PCMS) businesses at these two facilities.

 

In those inspections, FDA communicated its concerns regarding Philips' compliance with the Good Manufacturing Practices (GMP) requirements of the Food Drug and Cosmetic Act, focusing on how Philips addressed quality issues with specific components of Philips defibrillators (including the R92 resistor).