Bergen Medical Products, Inc. – FDA 483, Sep 11, 2019

Bergen Medical Products, Inc. in Morris Plains, NJ, was inspected by the FDA, revealing significant deficiencies in its quality system for manufacturing medical devices. The inspection found a lack of proper documentation for complaint investigations, design history files, management reviews, and corrective/preventive actions. Additionally, the firm failed to establish written Medical Device Reportability procedures and could not locate essential quality system documents.