# FDA 483 - TacPro LLC - February 22, 2024

Source: https://www.globalkeysolutions.net/records/483/tacpro-llc/43808c4a-e143-4f34-8c17-5581920b98a8

> FDA 483 for TacPro LLC on February 22, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TacPro LLC
- Inspection Date: 2024-02-22
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Creganna Medical, Inc. in Plymouth, MN, revealed that procedures for training and identifying training needs were not adequately established. Specifically, operators were observed deviating from documented work instructions during the manufacturing of catheter products. These deviations indicate a failure to ensure personnel are properly trained to perform their assigned responsibilities.

## Related Documents

- [483 - 2020-02-28](https://www.globalkeysolutions.net/records/483/tacpro-llc/d2bc046a-37f9-4c0f-b7e2-d4abea69e84b)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/tyler-r-courtney/08ea96c4-cd5a-4793-b7e4-fb2b9ee2b9ef)

Company: https://www.globalkeysolutions.net/companies/tacpro-llc/d3c305fa-469f-4e69-95f6-225f8887229a

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