FDA 483 - Spacelabs Healthcare, Inc. - September 15, 2022

An FDA inspection of Spacelabs Healthcare, Inc. in Snoqualmie, WA, a medical device manufacturer, identified one observation. The firm's procedures for acceptance activities were found to be inadequately established, specifically concerning the switching rules for sampling plans for a controller board used in their 700/900 Ventilator. This indicates a lapse in quality system adherence regarding product acceptance.