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

Newton Implant Systems, Inc., an HCT/P storage and distributor in Vista, CA, was cited for failing to follow established procedures for warehouse maintenance. Specifically, the firm did not adhere to its own SOP for recording maintenance activities and verifying cleanliness, leading to incomplete records for numerous units of tissue that have been shipped or are currently in storage. This indicates a lapse in maintaining core Current Good Tissue Practice (CGTP) requirements.