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Regulatory News | 01 November 2017 | By Zachary Brennan
Following its manufacture and distribution of adulterated automatic external defibrillators (AEDs) and Q-CPR meters, which the U.S. Food and Drug Administration (FDA) said put people at risk, US District Judge Denise Casper on Tuesday entered a consent decree of permanent injunction between the US and Andover, MA-based Philips North America LLC and two company officers.
Under a complaint filed on behalf of FDA and alongside the consent decree, Philips was said to be 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 based on noncompliance with quality system regulations.
"AEDs are life-saving tools and are designed to be used by the general public or professionals in an emergency," Melinda Plaisier, associate commissioner for regulatory affairs at FDA, said in a statement. "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' Emergency Care and Resuscitation business unit to cease operations at its Massachusetts and Bothell, WA, facilities, with certain exceptions, until it completes corrective actions, including the hiring of a qualified third-party CGMP consultant to inspect the business unit. The expert is expected to provide FDA with a report on the company's compliance, and the agency will conduct an inspection of both manufacturing facilities before Philips can resume manufacturing.
Last month, the company first announced the consent decree and said it would suspend the manufacture of some defibrillators, and back in February, the company issued a medical device correction.
The company said it would see an impact of about €80 million ($93 million) as a result of the issues in the final quarter of 2017 and all of 2018, mostly due to "the suspension of production, profit disgorgement payments, and incremental costs to prepare for and handle the regulatory inspections."
Tags: Philips, consent decree, defibrillators