FDA 483 - Bergen Medical Products, Inc. - September 11, 2019
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
- Person
ID · bfa88c53-7498-4567-afe0-4b6833320441