The FDA said it observed potential violations of federal medical device safety rules when inspecting a Philips Respironics manufacturing facility connected to the Class I recall of more than 15 million respiratory devices.
The FDA recently requested additional safety testing on replacement materials and issued a Form 483. The form details how Philips and its foam supplier were aware for years that polyester-based polyurethane (PE-PUR) sound abatement foam could break down and potentially enter a device’s air pathway, causing health problems for users.
In the Form 483, FDA alerted management at the Royal Philips (NYSE:PHG) subsidiary of conditions that the inspector considered possible violations of the U.S. Food, Drug and Cosmetic Act or related regulations. The post-inspection report is not a determination of wrongdoing and will be considered by the FDA along with any evidence or documents collected from the facility and responses offered by Philips.