Philips Gets Warning Letter From US FDA on Device Facilities (1)

Oct. 28, 2025, 4:08 PM UTC

Royal Philips NV received a letter from the US Food and Drug Administration warning that three manufacturing sites don’t meet standards, a blow to efforts to draw a line under high-profile issues with some of its products.

The medical equipment maker’s shares fell as much as 8.3% in Amsterdam trading, the most since April, and were 5.4% lower at 5 p.m.

The inspections concerned two Philips Ultrasound facilities in the US, and a Dutch site that makes two products for the Enterprise Informatics business, the company said in an emailed statement.

The warning is a setback for the ...

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