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."