FDA 483 - Bergen Medical Products, Inc. - September 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.