FDA reaches agreement with automatic external defibrillator manufacturer over quality control issues
Company must cease manufacturing until corrective action is taken.
U. S. District Judge Denise J. Casper entered a consent decree of permanent injunction yesterday between the U.S. and Philips North America LLC (doing business as Philips Medical Systems and Philips Healthcare) of Andover, Massachusetts, and two of the company’s officers, Carla Kriwet, business group leader for the Patient Care and Monitoring Solutions (PCMS) business group, and Ojas Buch, vice president, head of quality and regulatory for PCMS. The PCMS business group includes the Emergency Care and Resuscitation (ECR) business unit, which markets automatic external defibrillators (AEDs) and Q-CPR Meters.
With limited exceptions, the consent decree prohibits Philips and those individually named from manufacturing, processing, packing, holding or distributing devices made by the 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 the complaint filed with the consent decree, Philips was responsible for the manufacture and distribution of adulterated devices 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. The complaint notes that the company 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 in a timely manner, Philips distributed adulterated products that put people at risk.”
The consent decree requires Philips’ ECR business unit to cease operations at its Massachusetts and Washington facilities, with certain exceptions, until it completes corrective actions, including hiring a qualified third-party CGMP expert to inspect its ECR business unit to ensure it is fulfilling the QS regulation requirements of the FD&C Act. The expert will provide the FDA with a report on the company’s compliance and the agency will conduct an inspection of both manufacturing facilities before allowing Philips to resume manufacturing.
The complaint was filed by the U.S. Department of Justice on behalf of the FDA.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.