FDA 483 - Siemens Medical Solutions USA, Inc - October 26, 2022

An FDA inspection of Siemens Medical Solutions USA, Inc. in Malvern, PA, revealed significant deficiencies in the installation and documentation processes for their angiographic X-ray systems. The firm failed to properly document installation inspections and test results, lacked calibration documentation for testing equipment, and had incomplete assembly installation records. These issues indicate a breakdown in the firm's quality system regarding medical device installation and associated record-keeping.