The FDA today said a US District Judge signed an order prohibiting Royal Philips (NYSE:PHG) and its emergency care and resuscitation biz from producing and distributing AEDs made at its Andover, Mass. and Bothell, Wash.-based facilities until they return to compliance with FDA regulations.
In a press release, the agency said that US District Judge Denise Casper entered a consent decree of permanent injunction against Philips, patient care and monitoring service biz group lead Carla Kriwet and PCMS quality and regulatory head Ojas Buch. The decree limits the company from “manufacturing, processing, packing, holding or distributing devices made by the ECR business unit,” according to the release.
According to the FDA complaint, Philips produced AEDs in violation of current good manufacturing practice requirements due to noncompliance with quality system regulations.
The complaint includes a noted failure to establish and maintain adequate processes “regarding its corrective and preventative action procedures, design verification and validation controls, and product specifications.”
“AEDs are life-saving tools and are designed to be used by the general public or professionals in an emergency. People rely on these devices to work when needed. By not adequately addressing corrective and preventative actions with their AEDs in a timely manner, Philips distributed adulterated products that put people at risk,” FDA regulatory affairs associate commissioner Melinda Plaisier said in a press release.
Under the decree, Philips is ordered to cease operations at both facilities, with exceptions, until its corrective actions are completed. These actions include hiring a third-party CGMP expert to inspect the ECR biz and assure its QS regulation requirements are met.
Philips announced it had made the deal with the US Dept. of Justice in mid October.
