# FDA 483 - Spineology, Inc. - February 15, 2022

Source: https://www.globalkeysolutions.net/records/483/spineology-inc/b37c107f-6f95-41da-9ced-886491c80a55

> FDA 483 for Spineology, Inc. on February 15, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Spineology, Inc.
- Inspection Date: 2022-02-15
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Spineology, Inc. in Saint Paul, MN, a medical device manufacturer, revealed two significant observations. The firm failed to adequately validate software used in its quality system and demonstrated inadequate risk analysis for incidents involving death or serious injury, specifically regarding documented MDRs.

## Related Documents

- [483 - 2025-04-17](https://www.globalkeysolutions.net/records/483/spineology-inc/6cfd9ed6-1b38-4fb0-b5bc-8b03c059bdf1)

## Related Officers

- [Albert L. Nguyen](https://www.globalkeysolutions.net/people/albert-l-nguyen/496338d0-71c4-43da-92f0-09515559d9fc)
- [Investigator ](https://www.globalkeysolutions.net/people/christina-l-bigham/f3da8e26-4a8c-43a8-8070-349fe4500289)

Company: https://www.globalkeysolutions.net/companies/spineology-inc/20fa6288-6ca8-4bd6-8dca-27e8c9ada033

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d