# FDA 483 - Paragon Medical, a division of NN Inc. - May 20, 2025

Source: https://www.globalkeysolutions.net/records/483/paragon-medical-a-division-of-nn-inc/1edef631-3be9-49ae-a90e-ae2a701e1f5b

> FDA 483 for Paragon Medical, a division of NN Inc. on May 20, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Paragon Medical, a division of NN Inc.
- Inspection Date: 2025-05-20
- Product Type: device
- Office Name: Detroit District Office
- Summary: An FDA inspection of Paragon Medical, a division of NN Inc. in Indianapolis, IN, revealed deficiencies in process validation. Specifically, the firm failed to adequately validate its passivation system, including not revalidating with new worst-case materials and not challenging extreme conditions as outlined in its protocol. This indicates a significant lapse in ensuring product quality and safety.

## Related Officers

- [Melina L. Rodriguez-Upton](https://www.globalkeysolutions.net/people/melina-l-rodriguez-upton/0b540980-5708-4251-8ea6-6254375506f1)

Company: https://www.globalkeysolutions.net/companies/paragon-medical-a-division-of-nn-inc/e3ddce10-9db4-40ad-83f8-0ce31cdbd56d

Office: https://www.globalkeysolutions.net/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03