# FDA 483 - Bergen Medical Products, Inc. - September 11, 2019

Source: https://www.keypedia.com/records/483/bergen-medical-products-inc/bfa88c53-7498-4567-afe0-4b6833320441

> FDA 483 for Bergen Medical Products, Inc. on September 11, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bergen Medical Products, Inc.
- Inspection Date: 2019-09-11
- Product Type: device
- Office Name: New Jersey District Office
- Summary: 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.

## Related Officers

- [Melissa Zuppe](https://www.keypedia.com/people/melissa-zuppe/e34e3943-0e3c-4a24-983d-6ac8aa2cc906)

Company: https://www.keypedia.com/companies/bergen-medical-products-inc/cbe907b7-c4ef-481a-bd44-a134f9bf8bf9

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248