FDA 483 - GE Healthcare Finland Oy - May 16, 2024

GE Healthcare Finland Oy, a medical device manufacturer in Helsinki, Finland, was cited with four observations during an FDA inspection. The inspection revealed significant deficiencies in the design control processes for their TruSignal SpO2 sensors, including inadequate design verification, incorrect translation of design into production specifications, and insufficient documentation of design outputs. Additionally, the firm's sampling plans for electrical safety verification lacked valid statistical rationale.