FDA 483 - Exactech, Inc. - November 17, 2021

An FDA inspection of Exactech, Inc. in Gainesville, FL, identified four significant observations related to their medical device manufacturing. The firm failed to adequately translate device design into production specifications, particularly concerning oxidation prevention in packaging. Additionally, critical manufacturing processes, such as vacuum sealing, lacked proper validation, and procedures for accepting incoming components were not adequately established. Finally, sampling plans for shelf-life studies were found to lack a valid statistical rationale.