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US FDA flags quality issues at three Philips' facilities
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US FDA flags quality issues at three Philips' facilities
Oct 28, 2025 8:57 AM

Oct 28 (Reuters) -

The U.S. Food and Drug Administration has flagged three of

Philips' medical device facilities after inspections

found they had failed to meet required manufacturing standards,

according to an update on the agency's website on Tuesday.

The FDA issued a warning letter to the Dutch medical device

maker about the facilities at Bothell, Washington and

Reedsville, Pennsylvania in the U.S., and Eindhoven in the

Netherlands.

The devices made at these facilities are considered

"adulterated" under U.S. law due to non-compliance with current

good manufacturing practices, the FDA said in the letter.

U.S.-listed shares of the medical device company were

down nearly 5% in morning trading.

The inspected sites produce various types of medical

equipment, including ultrasound machines, their components, as

well as software used for cardiac assessments and patient

monitoring.

Philips said it takes the warning "very seriously" and has

submitted a formal response to the FDA, in line with regulatory

requirements.

The company continues to manufacture and sell these

products, and that it does not expect any material commercial

impact from the warning letter, it added.

"This seems a relatively minor issue in which Philips did

not correctly adhere to the required complaint documentation,"

said Marc Hesselink, analyst at ING FM. "We do not expect that

this has a material negative impact on Philips."

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