FDA 483 - E. Benson Hood Laboratories, Inc. - February 20, 2024

E. Benson Hood Laboratories, Inc. in Pembroke, MA, was inspected and found to have significant deficiencies in its quality system. The inspection revealed inadequate procedures for design changes, complaint handling, and corrective and preventive actions, as well as a failure to document acceptance activities for various medical devices. These issues indicate a systemic lack of control over critical manufacturing and quality processes.