Philips Healthcare has temporarily halted production at its Cleveland manufacturing facility following an inspection by the U.S. Food and Drug Administration (FDA).
The site is one of several global facilities that manufacture Philips' CT, PET/CT, and other molecular imaging equipment.
In a prepared statement, Philips stated that the January visit from the FDA found "certain issues in the general area of manufacturing process controls" that were brought to the company's attention. There is "no indication of product safety issues," Philips noted. "Our customers can remain confident in the safety of our products."
Philips voluntarily suspended production at the Cleveland facility, primarily to upgrade manufacturing process controls to resume production as soon as possible.
The company expects to resume shipping some products from the Cleveland facility in the second quarter of this year "with others to follow in the second half of 2014," stated Mario Fante, Philips' senior manager of public relations-strategic healthcare communications, in an email to AuntMinnie.com.
Some medical devices affected by the temporary shutdown in Cleveland are also manufactured at Philips facilities outside the U.S., including Suzhou and Shenyang, China; Lagoa Santa, Brazil; and Haifa, Israel.
Production of those devices at those other facilities will continue for distribution in non-U.S. markets, Fante wrote.
Service of Philips' products has not been affected by the Cleveland situation.
