Philips Healthcare (NYSE:PHG) halted work at an Ohio manufacturing facility after an FDA inspection turned up some concerns with process controls, a company spokesman confirmed with MassDevice.com today.
"Philips announced a voluntary, temporary suspension of production at the Cleveland facility, primarily to upgrade manufacturing process controls in order to resume production as soon as possible," Philips senior PR manager Mario Fante said. "This action was not ordered or otherwise required by the FDA."
The facility primarily produced computer tomography systems and advanced molecular imaging equipment, Fante told us. There’s no indication that the manufacturing concerns are tied to any product safety issues.
"Our customers can remain confident in the safety of our products," Fante said.
The facility should be fully up and running by the 2nd half of 2014, with some products ready to resume shipping in Q2 this year.
"We take this matter very seriously, and by this voluntary action we demonstrate that we are committed to the highest standards of product quality and compliance with government safety regulations everywhere in the world for medical devices, and we will continue to deliver high quality products to our customers worldwide," Fante told us.
Some have speculated that the so-called "process controls" came down to a matter of missed documentation rather than any true product concerns.
"It’s more like they didn’t do their paperwork correctly – they didn’t dot all their i’s and cross all their t’s," MD Buyline clinical analyst Loretta Loncoske told DOTmed News.
PHG shares were down 1.7% in early afternoon trading today, going for $34.46 apiece as of about 12:50 p.m. EST.