par Thomas Dworetzky
, Contributing Reporter | November 02, 2017
The FDA has reached a deal with Philips North America (also known as Philips Medical Systems and Philips Healthcare) over quality control issues with its automatic defibrillator manufacturing process – announced with a consent decree of permanent injunction entered by U.S. district judge Denise J. Casper.
The October 31 decree, with limited exceptions, “prohibits Philips and those individually named from manufacturing, processing, packing, holding or distributing devices made by the Emergency Care and Resuscitation (ECR) business unit at their Andover, Massachusetts, and Bothell, Washington, facilities until they comply with the Federal Food, Drug and Cosmetic Act (FD&C Act) and FDA regulations, in addition to other requirements,” according to an FDA release.
“We are committed to delivering high quality, innovative products and solutions, and we take this matter very seriously,” Chief Business Leader Connected Care & Health Informatics at Royal Philips Carla Kriwet said in a statement when news of the deal was first announced in mid-October.
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She emphasized that the company was “fully prepared” to satisfy the decree and hoped to start defibrillator production again in 2018.
“Over the last years, we have made significant investments in our Quality Management System, with the change in our company-wide quality leadership and the launch of new standards and initiatives across all our businesses and markets,” she said, adding that the company would continue “to further enhance our quality management throughout Philips.”
The decree also enjoined two company officers – Kriwet and Ojas Buch, PCMS VP of quality and regulatory assurance, according to the announcement.
“AEDs are lifesaving tools and are designed to be used by the general public or professionals in an emergency,” said Melinda Plaisier, associate commissioner for regulatory affairs at the FDA, advising that “Philips distributed adulterated products that put people at risk.”
The complaint holds that the company was at fault because its AEDs and Q-CPR Meters were made “in violation of current good manufacturing practice (CGMP) requirements under the FD&C Act based on noncompliance with quality system (QS) regulations.”
In addition, Philips didn't set up “ adequate processes” to fix the issues, says the government.
The decree will suspend operations, with few exceptions, in those two locations until the company “completes corrective actions, including hiring a qualified third-party CGMP expert” to make sure it is up to quality requirements – and reports back to the FDA that it is OK to open the facilities again.
In mid-October, when the company had agreed to the terms, Kriwet told HCB News
, "Following FDA inspections at the Andover and Bothell facilities from 2009 to 2015, FDA investigators made observations regarding Philips' compliance with the Good Manufacturing Practices and medical device reporting requirements of the Food, Drug and Cosmetic Act, with a focus on how Philips addressed issues of its defibrillators."
To address these concerns the company has put steps in place to restructure its quality control function, she noted, and put in new leadership, retrain personnel and introduce culture change initiatives.
"Philips takes this matter extremely seriously," said Kriwet. "The company is committed to fulfilling the terms of the Consent Decree, and we have already taken actions since 2015 to address this."