# FDA 483 - Polygon Medical, Inc. - April 25, 2024

Source: https://www.keypedia.com/records/483/polygon-medical-inc/45ff6605-d089-4fd4-a83f-005a663e17ad

> FDA 483 for Polygon Medical, Inc. on April 25, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Polygon Medical, Inc.
- Inspection Date: 2024-04-25
- Product Type: device
- Office Name: New England District Office
- Summary: An FDA inspection of Polygon Medical, Inc. in Holliston, MA, revealed significant deficiencies in their quality management system. Observations included inadequate procedures for corrective and preventive actions, failures in complaint handling, and a lack of internal quality audits. These issues indicate a need for comprehensive improvements in their device manufacturing processes.

## Related Officers

- [investigator](https://www.keypedia.com/people/james-p-finn/70e5c36c-2711-449b-bf73-e08b4dd58449)

Company: https://www.keypedia.com/companies/polygon-medical-inc/4529ee7c-f982-4759-a7cd-48f2c53cc0f1

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144