FDA 483 - Hologic, Inc - November 04, 2025

Hologic, Inc. in Marlborough, MA, received a Form FDA 483 following an inspection of its medical device facility. The inspection revealed significant deficiencies in corrective and preventive action procedures, complaint handling, and management review processes, particularly concerning risk assessments for breast biopsy systems. These issues, including repeat observations from a previous inspection, indicate a lack of adequate controls to ensure device safety and quality.