FDA 483 - RS Medical - February 27, 2020

International Rehabilitative Sciences, Inc. in Vancouver, WA, a manufacturer of Class I and Class II medical devices, was inspected by the FDA from February 24-27, 2020. The inspection revealed significant deficiencies in the firm's quality system, primarily concerning the inadequate establishment and implementation of various procedures. Observations included issues with document control, device history records, complaint handling, nonconforming product control, and corrective and preventive actions.