FDA 483 - Siemens AG/Siemens Healthcare GmbH - January 26, 2023

An FDA inspection of Siemens AG/Siemens Healthcare GmbH in Forchheim, Germany, revealed significant deficiencies in their quality system. The firm failed to adequately validate device software, particularly for revisions addressing Class II recalls, and also lacked proper documentation for corrective and preventive action activities. These issues indicate a breakdown in quality control for medical device manufacturing.