483
Avalign Integrated Medical Solutions, Inc.FDA 483 - Avalign Integrated Medical Solutions, Inc. - June 28, 2022
Record Details
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.
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ID · 9c1fd538-b7db-411d-aac7-5f67eef7fe5d