# FDA 483 - Sofregen Medical Inc. - July 31, 2019

Source: https://www.keypedia.com/records/483/sofregen-medical-inc/36b8c415-c7f2-4c64-a734-6a43f0bbe308

> FDA 483 for Sofregen Medical Inc. on July 31, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sofregen Medical Inc.
- Inspection Date: 2019-07-31
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: Sofregen Medical Inc. in Medford, MA, was inspected by the FDA from July 29-31, 2019, and received one observation. The inspection revealed a deficiency in maintaining the device master record for their SERI Surgical Scaffold, specifically regarding current labeling. This indicates a moderate compliance issue related to quality system documentation for a distributed medical device.

## Related Officers

- [Sara M. Richardson](https://www.keypedia.com/people/sara-m-richardson/460de568-e9ad-49bd-bf63-291bea7731db)

Company: https://www.keypedia.com/companies/sofregen-medical-inc/b316723d-d2ba-4433-9edc-d6cf709bee77

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94