Philips Agrees to Suspend Defibrillator Production

Royal Philips agreed to enter into a consent decree with the U.S. Department of Justice to suspend production of its automated external defibrillators at two of its U.S. manufacturing sites.

According filings in the U.S. District Court for Massachusetts, the FDA attempted to address several quality violations by issuing Form 483 reports, warning letters and meetings with company officials since 2009, but was not satisfied with the company’s response.

The GMP nonconformities identified at the Andover, Massachusetts and Bothell, Washington sites included inadequate procedures for implementing CAPAs, failing to validate changes to a cleaning process, software and device changes, among other violations.