The US Food and Drug Administration (FDA) has warned Philips about manufacturing violations at the company’s facility in Suzhou, China, where computed tomography (CT) and ultrasound systems are produced, following an inspection in October 2023.
The warning from the agency’s Center for Devices and Radiological Health followed an inspection that cited good manufacturing practice (GMP) infractions related to the manufacture of the imaging devices and concluded the products were adulterated. FDA asked the company to notify the agency in writing within 15 days of steps taken to address the violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and prevent similar problems from happening in the future…
