FDA 483 - 3D Diagnostix Inc. - November 21, 2025

An FDA inspection of 3D Diagnostix Inc. in Allston, MA, from November 10-21, 2025, revealed eight significant quality system deficiencies. The firm failed to establish design history files, adequately validate manufacturing processes, properly handle complaints, or maintain effective corrective and preventive action procedures. Additionally, issues were noted with environmental controls, device history records, supplier management, and incoming product acceptance, indicating a broad lack of adherence to regulatory requirements for their medical devices.