FDA 483 - Avalign Integrated Medical Solutions, Inc. - June 28, 2022

Avalign Integrated, LLC, a medical device manufacturer in Mentor, OH, was inspected by the FDA from June 22-28, 2022. The inspection revealed significant issues with the firm's quality system, specifically regarding the effectiveness of corrective and preventive actions, the handling of product complaints, and the documentation of in-process inspections for Class II bone fixation screws. These findings indicate a need for improved adherence to established procedures and quality control measures.