# FDA 483 - Paragon 28, Inc. - April 24, 2025

Source: https://www.globalkeysolutions.net/records/483/paragon-28-inc/8214d63a-4666-4374-afea-5b60b860e85a

> FDA 483 for Paragon 28, Inc. on April 24, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Paragon 28, Inc.
- Inspection Date: 2025-04-24
- Product Type: device
- Office Name: Denver District Office
- Summary: An FDA inspection of Paragon 28, Inc. in Englewood, CO, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately establish process control procedures, leading to the production and release of non-compliant Patient Specific Talus Spacers and issues with product labeling expiration dates. Additionally, acceptance procedures were not properly established, resulting in the release of implants and instrument trials without sufficient documentation of conformance to design specifications.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/matthew-m-vernon/f77e8c18-8614-49e3-9b19-3327b7fe7648)

Company: https://www.globalkeysolutions.net/companies/paragon-28-inc/71e9a57c-417a-4ed3-868f-57ec417b3c3d

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face