# FDA 483 - Proactive Medical Products - November 09, 2021

Source: https://www.keypedia.com/records/483/proactive-medical-products/d94b9bd8-b440-4504-85ec-70f086be9f51

> FDA 483 for Proactive Medical Products on November 09, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Proactive Medical Products
- Inspection Date: 2021-11-09
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Proactive Medical Products in Mount Vernon, NY, a medical device manufacturer and importer, revealed significant deficiencies in their quality system. The firm failed to maintain written procedures for serious incident handling, conduct regular quality audits, and ensure management review of the quality system's effectiveness. These issues indicate a lack of fundamental controls over their operations.

## Related Officers

- [investigator](https://www.keypedia.com/people/kwong-p-lee/f4778925-1fad-4988-9e39-86482896c4fa)

Company: https://www.keypedia.com/companies/proactive-medical-products/736324cc-57b3-42e3-b2c6-2a594fc5acf8

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961