AHA - American Hospital Association

10/30/2025 | News release | Distributed by Public on 10/30/2025 16:04

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.

Quality & Patient Safety
Compliance
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