# FDA 483 - Centracare St. Cloud Hospital - Irb - February 18, 2022

Source: https://www.keypedia.com/records/483/centracare-st-cloud-hospital-irb/e9c8a469-5063-4a80-b623-f1c63ceacb9b

> FDA 483 for Centracare St. Cloud Hospital - Irb on February 18, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Centracare St. Cloud Hospital - Irb
- Inspection Date: 2022-02-18
- Product Type: other
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Centracare St. Cloud Hospital - Irb, an Institutional Review Board, revealed significant deficiencies in its written procedures. The IRB failed to establish and maintain adequate documentation for various critical processes, including reporting unanticipated problems, noncompliance, and determining review frequency or device risk. These issues indicate a lack of robust procedural controls for human subject protection.

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/kellie-l-thommes/255a1b92-cd56-41f5-9622-82e8a629e153)

Company: https://www.keypedia.com/companies/centracare-st-cloud-hospital-irb/8de7d0dc-d983-4c06-8616-483edd99f3f4

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