FDA 483 - Freespira, Inc. - April 29, 2022

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.