tietatovenaar schreef op 28 oktober 2025 15:38:
Investing.com -- Koninklijke Philips N.V. (NYSE:PHG) stock fell 8% after the U.S. Food and Drug Administration (FDA) issued a warning letter to the company regarding multiple violations found during inspections of its medical device facilities.
The FDA conducted inspections at Philips Ultrasound facilities in Bothell, Washington and Reedsville, Pennsylvania, as well as at Philips Medical Systems Nederland in the Netherlands between January and March 2025. The agency identified several violations related to quality control systems, complaint handling, corrective actions, and reporting requirements.
Among the key issues cited were failures to establish proper procedures for evaluating complaints, implementing corrective actions, and validating device designs. The FDA also found that Philips failed to properly report device corrections and removals within the required 10-day timeframe.
The warning letter specifically mentioned problems with ultrasound systems and transducers, including the EPIQ Elite Ultrasound system and various transducer models. Some transducers were found to have been refurbished and distributed beyond their established three-year useful life.
The FDA has given Philips 15 business days to respond with specific steps to address the violations. The agency warned that failure to adequately address these issues could result in regulatory actions including seizure, injunction, and civil money penalties.
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