# FDA 483 - Statrad, LLC - October 30, 2019

Source: https://www.keypedia.com/records/483/statrad-llc/3af5f5e0-d6d3-411f-b219-851d24abf589

> FDA 483 for Statrad, LLC on October 30, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Statrad, LLC
- Inspection Date: 2019-10-30
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: NucleusHealth, LLC in San Diego, CA, a specification developer and manufacturer, was inspected by the FDA. The inspection revealed significant issues with design controls for their Nucleus.io software, including inadequate design input procedures and lack of verification testing documentation. Additionally, the firm failed to maintain a device master record and had not adequately established training procedures for personnel.

## Related Officers

- [Jenny L Mccardell](https://www.keypedia.com/people/jenny-l-mccardell/b8fa04db-6acc-48d1-b0be-56777704ae51)

Company: https://www.keypedia.com/companies/statrad-llc/18a8e041-c034-43fa-a6a8-06a17181040a

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6