483
Freespira, Inc.FDA 483 - Freespira, Inc. - April 29, 2022
Record Details
Freespira, Inc. in Kirkland, WA, a medical device manufacturer, was inspected by the FDA from April 27-29, 2022. The inspection revealed significant deficiencies in the firm's quality system, specifically regarding complaint handling, corrective and preventive actions, and equipment maintenance. These issues indicate a lack of adequate procedures and implementation for critical quality processes.
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ID · 65235739-79ee-4043-b3a9-84cf3af3b967