FDA 483 - In2bones USA, LLC - March 08, 2019

An FDA inspection of In2bones USA, LLC in Memphis, TN, a specification developer, revealed three significant observations. The firm's risk analysis for medical devices was found to be inadequate, with an FMECA not updated to reflect new complaint data. Additionally, procedures for corrective and preventive actions lacked clear responsibilities for approving extensions and required rationale, and complaint handling procedures were deficient, as a complaint for a broken screw was not properly documented.