# FDA 483 - JSM SOLUTIONS LLC - January 10, 2024

Source: https://www.keypedia.com/records/483/jsm-solutions-llc/563cb6c3-e7cd-4b90-9085-8d633e705e1d

> FDA 483 for JSM SOLUTIONS LLC on January 10, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: JSM SOLUTIONS LLC
- Inspection Date: 2024-01-10
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: JSM SOLUTIONS LLC in Faribault, MN, was inspected and cited for significant deficiencies in its quality system. The firm was found to be manufacturing and distributing Class 1 and 2 medical devices without an established quality system, documented design inputs, or approved suppliers and consultants. These issues indicate a fundamental lack of control over critical aspects of medical device production and quality assurance.

## Related Officers

- [investigator](https://www.keypedia.com/people/tyler-r-courtney/08ea96c4-cd5a-4793-b7e4-fb2b9ee2b9ef)
- [Clifford F. Long](https://www.keypedia.com/people/clifford-f-long/846e5a0c-cb7c-421c-86aa-be9fddfbaaba)

Company: https://www.keypedia.com/companies/jsm-solutions-llc/c2aded19-9e7a-4a9d-8ded-354f3f177742

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