FDA 483 - Qualitel Corporation - December 05, 2019

Qualitel Corporation, a contract manufacturer of Class II medical devices in Everett, WA, was inspected by the FDA from December 2-5, 2019. The inspection revealed significant deficiencies in the firm's quality system, specifically concerning inadequate procedures for corrective and preventive actions, device history records, and equipment maintenance. These findings indicate a lack of adherence to established quality system requirements.