FDA 483 - Newton Implant Systems, Inc. - August 18, 2025

An FDA inspection of Newton Implant Systems, Inc., an HCT/P storage and distributor in Vista, CA, revealed a failure to follow procedures for core Current Good Tissue Practice (CGTP) requirements. Specifically, the firm did not maintain complete and current records for warehouse maintenance and cleanliness verification as required by their own SOP. This lapse affects numerous units of tissue that have been shipped out and are currently in storage.