R2 Digital Milling Technologies Inc. – FDA 483, Mar 12, 2026

An FDA inspection of R2 Digital Milling Technologies Inc. in Westwood, NJ, a medical device manufacturer, revealed 11 significant observations related to fundamental quality system deficiencies. The firm failed to adequately validate processes, manage risks, control production, transfer designs, evaluate suppliers, handle complaints, control nonconforming products, conduct internal audits, and comply with UDI and GUDID requirements. These widespread issues indicate a severely deficient quality management system.