Hologic, Inc – FDA 483, Sep 24, 2024

An FDA inspection of Hologic, Inc. in Marlborough, MA, revealed significant deficiencies in the design controls, corrective and preventive actions, and medical device reporting for their BioZorb implantable radiographic marker and its accessory device. The firm failed to adequately establish design inputs, conduct complete verification and validation testing, properly manage complaints, and report adverse events and field actions, indicating systemic quality system failures that could impact patient safety.