FDA 483 - Newton Implant Systems, Inc. - July 19, 2022

An FDA inspection of Newton Implant Systems, Inc. in San Diego, CA, revealed a significant deficiency regarding the lack of established written procedures for handling human bone products. The firm failed to implement appropriate procedures for the receipt, storage, shipment, and distribution of HCT/Ps, specifically bone graft products. These products were subsequently distributed to customers without the necessary procedural controls.