According to the complaint filed with the consent decree, Philips was responsible for the manufacture and distribution of adulterated devices because its AEDs and Q-CPR Meters were made in violation of current good manufacturing practice (CGMP) requirements under the FD&C Act based on noncompliance with quality system (QS) regulations. The complaint notes that the company failed to establish and maintain adequate processes regarding its corrective and preventative action procedures, design verification and validation controls, and product specifications.
Announcement
Posted 10/31/2017
