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
March 8-14 marks Patient Safety Awareness Week. The AHA has several resources including podcasts, videos and reports that show how AHA members are advancing…
Headline
The U.S. District Court for the Southern District of Florida March 6 ruled in favor of five Florida hospitals in a case challenging the methodology used by the…
Chairperson's File
This week, March 8-14, is Patient Safety Awareness Week. Delivering safe, quality care to all patients is the top priority for everyone working in hospitals…
Headline
The Department of Health and Human Services Office for Civil Rights Feb. 13 announced the launch of a program to implement and enforce statutory and regulatory…
Headline
The Food and Drug Administration has identified a Class I recall of certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus…
Headline
Thomas McGinn, M.D., senior executive vice president and chief physician executive officer at CommonSpirit Health, shares how the organization aligns…