(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 […]
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US FDA flags quality issues at three Philips’ facilities
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(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.”
(Reporting by Sruthi Narasimha Chari and Kamal Choudhury in Bengaluru, additional reporting by Piotr Lipinski and Clement Martinot in Gdansk; Editing by Leroy Leo)