Philips Healthcare suspends production at Ohio facility
Philips Healthcare temporarily has suspended production at its medical imaging facility in Highland Heights, Ohio, while it works to improve its quality control processes.
Philips stopped production voluntarily, but the shutdown was prompted by process-related issues that federal regulators identified during a recent inspection, according to a statement Philips e-mailed to Crain’s Cleveland Business.
However, “there is no indication” that those issues have affected the safety of the medical imaging machines made at the facility, according to the statement. Philips makes CT scanners and molecular imaging machines in Highland Heights.
“Our customers can remain confident in the safety of our products,” the company said in the statement.
The U.S. Food and Drug Administration has previously chided Philips’ Highland Heights facility for failing to meet standards the agency sets for medicaldevice manufacturing processes.
The FDA in 2011 sent Philips a warning letter pointing out several flaws in the processes that the facility used to prevent and correct manufacturing problems that could arise.
Philips did address those problems, according to another letter the FDA sent in 2012. In that letter, however, the FDA promised to keep an eye on the facility.