QView Medical, Inc. – FDA 483, Dec 10, 2021

An FDA inspection of QView Medical, Inc., a medical device manufacturer in Los Altos, CA, revealed significant deficiencies across its quality system. The firm was cited for inadequate procedures and documentation concerning software validation, corrective and preventive actions, design review, device history records, and internal quality audits. These findings indicate a systemic lack of adherence to established quality system requirements.