The U.S. Food and Drug Administration (FDA) said Tuesday that a district judge has ordered Philips North America to halt manufacturing the company’s automatic external defibrillators (AEDs) and Q-CPR Meters.
Philips North America does business as Philips Medical Systems and Philips Healthcare.
Under a consent decree, Philips’ emergency care and resuscitation (ECR) business unit, which is in charge of manufacturing the product, is to cease operations at its Massachusetts and Washington facilities until it completes corrective actions. The corrective action includes hiring a qualified third-party CGMP consultant to inspect the facilities.
According to the complaint filed with the consent decree, Philips was said to be responsible for the manufacture and distribution of adulterated devices after its AEDs and Q-CPR Meters were made in violation of current good manufacturing practice (CGMP) requirements of the Federal Food, Drug and Cosmetic Act (FD&C Act).
The complaint noted that company had failed 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,” said Melinda Plaisier, associate commissioner for regulatory affairs at the FDA. “People rely on these devices to work when needed. By not adequately addressing corrective and preventative actions with their AEDs promptly, Philips distributed adulterated products that put people at risk.”
In an Oct. 11 statement, Carla Kriwet, Philips business group leader for the Patient Care and Monitoring Solutions (PCMS) and one of the two officials cited in the consent decree, said, “We are committed to delivering high- quality, innovative products, and solutions, and we take this matter very seriously.”
The company is fully prepared to fulfill the terms of the decree and hope to resume the suspended defibrillator production next year, she added.
The decree allows Philips to continue the manufacture and distribution of certain automated external defibrillator (AED) models. The company also expects to continue the export of ECR devices once certain requirements are met, according to the statement.
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