FDA 483 - Barrett Technology, LLC - March 07, 2023

Barrett Technology, LLC, a medical device manufacturer in Newton, MA, was inspected and received a Form FDA 483 with five observations. The inspection revealed significant deficiencies in the firm's quality system, particularly concerning complaint handling, corrective and preventive actions, quality audits, training, and control of storage areas. These issues indicate a need for comprehensive procedural improvements to ensure product quality and regulatory compliance.