# FDA 483 - Spartronics Watertown LLC - October 28, 2021

Source: https://www.globalkeysolutions.net/records/483/spartronics-watertown-llc/a9a879d6-e15d-40e4-85b4-d3d7b32cebe3

> FDA 483 for Spartronics Watertown LLC on October 28, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Spartronics Watertown LLC
- Inspection Date: 2021-10-28
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Spartronics Watertown LLC in Watertown, SD, a medical device manufacturer, revealed a significant issue with their quality system. The firm failed to adequately establish and implement procedures for controlling nonconforming product. This indicates a moderate severity finding related to quality system deficiencies.

## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/christina-l-bigham/f3da8e26-4a8c-43a8-8070-349fe4500289)

Company: https://www.globalkeysolutions.net/companies/spartronics-watertown-llc/e52a7692-82f4-4aef-bee1-c982b8124b71

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