FDA issues warning letter to Philips on device facilities

The U.S. FDA issued a warning letter to Philips (PHG) regarding its medical device facilities in Washington, Pennsylvania, and the Netherlands. “During these inspections, FDA investigators determined that Philips Ultrasound and Philips Medical Systems Nederland B.V. manufacture a variety of medical devices, such as the EPIQ Elite Ultrasound system, manufactured at Bothell, Ultrasound Transducers manufactured at Reedsville, and the IntelliSpace Cardiovascular and the eCareManager, manufactured at Nederland. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act, these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.”