FDA 483 - Defibtech, LLC - March 25, 2025

Defibtech, LLC, a medical device manufacturer in Branford, CT, was cited with five observations during an FDA inspection for significant quality system deficiencies. These issues include failures in UDI submission, complaint handling, corrective and preventive actions, control of nonconforming product, and supplier management for its Automated Chest Compressors. The findings indicate a systemic lack of established and followed procedures across several critical areas of device manufacturing and quality control.