# FDA 483 - Neosoma, Inc. - February 21, 2025

Source: https://www.keypedia.com/records/483/neosoma-inc/cd8be919-152e-455c-b3ca-40d4161f4358

> FDA 483 for Neosoma, Inc. on February 21, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Neosoma, Inc.
- Inspection Date: 2025-02-21
- Product Type: device
- Office Name: New England District Office
- Summary: An FDA inspection of Neosoma, Inc. in Groton, MA, a manufacturer of medical device software, revealed significant deficiencies in their quality system. The firm failed to maintain required device master and device history records for their Neosoma HGG image processing software. Additionally, procedures for the review and disposition of nonconforming products were inadequate, with investigations not being documented as required.

## Related Officers

- [Nabil Nakhoul](https://www.keypedia.com/people/nabil-nakhoul/d676e9c9-566c-4e59-84e8-1dc474e4e48d)

Company: https://www.keypedia.com/companies/neosoma-inc/e2d63671-b738-4af5-b2d1-072dfce312df

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