# FDA 483 - TacPro LLC - February 28, 2020

Source: https://www.keypedia.com/records/483/tacpro-llc/d2bc046a-37f9-4c0f-b7e2-d4abea69e84b

> FDA 483 for TacPro LLC on February 28, 2020. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: TacPro LLC
- Inspection Date: 2020-02-28
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Creanna Medical Inc. in Plymouth, MN, revealed significant deficiencies across its quality management system. The firm failed to adequately establish procedures for corrective and preventive actions, complaint handling, process validation, and control of non-conforming products. These issues indicate a systemic breakdown in maintaining a robust quality system.

## Related Documents

- [483 - 2024-02-22](https://www.keypedia.com/records/483/tacpro-llc/43808c4a-e143-4f34-8c17-5581920b98a8)

## Related Officers

- [investigator](https://www.keypedia.com/people/jennifer-s-ness/532f8a81-e393-4e83-b5f2-a72362e966de)
- [Clifford F. Long](https://www.keypedia.com/people/clifford-f-long/846e5a0c-cb7c-421c-86aa-be9fddfbaaba)

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

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