FDA 483 - Foresight Imaging, LLC - December 12, 2025

Foresight Imaging, LLC in Chelmsford, MA, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included inadequate procedures for complaint handling, ineffective corrective and preventive actions, and a failure to establish a complete design history file. These issues indicate a lack of robust controls over critical aspects of medical device manufacturing and quality assurance.