# FDA 483 - Junopacific Inc. - January 24, 2025

Source: https://www.keypedia.com/records/483/junopacific-inc/f66e3bb6-fe61-4dd0-a4b6-6cbb3fdb81c5

> FDA 483 for Junopacific Inc. on January 24, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Junopacific Inc.
- Inspection Date: 2025-01-24
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Junopacific Inc., a medical device manufacturer in Minneapolis, revealed significant deficiencies in their quality system. The firm failed to adequately validate processes, including revalidation after a facility move, and did not properly control non-conforming products. These issues indicate a lack of adherence to established procedures and regulatory expectations for medical device manufacturing.

## Related Officers

- [Shawn Choi](https://www.keypedia.com/people/shawn-choi/77845db3-46a3-4d0f-b94c-428bc251c0dc)
- [Investigator ](https://www.keypedia.com/people/christina-l-bigham/f3da8e26-4a8c-43a8-8070-349fe4500289)

Company: https://www.keypedia.com/companies/junopacific-inc/9077fa59-f1f3-4c7f-80f1-c471f3320eca

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