FDA sends warning letter to Philips due to quality issues
The Food and Drug Administration sent a warning letter to Philips last month due to quality violations found at three of its medical device facilities earlier this year. The letter, dated Sept. 9, highlights nine violations found at the facilities, located in Washington, Pennsylvania and the Netherlands. The FDA urged Philips to investigate and determine the causes of the violations and take swift action to bring impacted products into compliance.
Related News Articles
Headline
A multistate cyclospora outbreak linked to iceberg lettuce has been declared over, the Centers for Disease Control and Prevention and Food and Drug…
Perspective
Twenty-five years ago, our nation experienced one of the darkest days in its history. The terrorist attacks of Sept. 11, 2001, took thousands of innocent lives…
Headline
The AHA Aug. 31 joined a coalition led by LeadingAge and other national healthcare organizations in submitting comments to the Centers for Medicare &…
Headline
The Federal Office of Rural Health Policy’s Rural Health Redesign Center will host a webinar on Sept. 24 at 2 p.m. ET, where hospital CEOs will discuss the…
Headline
Joy A. Rhoden, AHA senior vice president and executive director of health outcomes and care transformation, explores the economic impact of health disparities…
Headline
The Food and Drug Administration has issued an early alert for all automated Impella controllers by Abiomed following an issue that has caused three deaths and…