483
Spacelabs Healthcare, Inc.Spacelabs Healthcare, Inc. – FDA 483, Sep 15, 2022
Record Details
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.
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ID · c778636d-7a55-4487-b0ad-9440f3312dc3
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