FDA 483 - Siemens Healthcare Diagnostics, Inc. - March 08, 2022

The 483 report for Siemens Healthcare Diagnostics, Inc. identifies significant issues with their corrective and preventive action procedures and the timely submission of Medical Device Reports (MDRs). The firm failed to initiate formal CAPAs for numerous late MDRs and repeatedly submitted MDRs beyond the required 30-day timeframe for various IVD assays and immunoassay systems, including those for Alpha Fetoprotein, Anti-Hepatitis B surface Antigen 2, and SARS-CoV-2 Total. These failures indicate a systemic problem in their complaint handling and regulatory reporting processes.