FDA 483 - Litron LLC - March 22, 2022

Litron LLC, a medical device contract manufacturer in Agawam, MA, was inspected by the FDA from March 9-22, 2022. The inspection revealed significant deficiencies in the firm's quality system, including inadequate procedures for corrective and preventive actions, change control, complaint handling, and employee training. These issues indicate a systemic lack of control over critical manufacturing processes and quality management.