FDA 483 - Quadm Technologies, Llc - April 25, 2022

Quadm Technologies, Llc in Hamilton, NJ, was inspected from April 12-25, 2022, and received a Form FDA 483 with seven observations. The inspection revealed significant deficiencies in the firm's quality system, particularly concerning documentation of corrective and preventive actions, equipment calibration, process controls, device history records, process validation, complaint handling, and control of non-conforming product. These issues indicate a broad lack of established and followed procedures for critical manufacturing and quality processes.