FDA 483 - Siemens Medical Solutions USA, Inc. - January 06, 2023

An FDA inspection of Siemens Medical Solutions USA, Inc. in Issaquah, WA, revealed significant deficiencies in their quality system for manufacturing diagnostic ultrasound systems. The firm failed to establish adequate procedures for corrective and preventive actions, design controls, and complaint handling. Additionally, their sampling plans for transducer testing lacked valid statistical rationale, indicating a need for improved regulatory compliance.