# FDA 483 - Avera McKennan Hospital IRB #1 DBA Avera IRB #1 - July 10, 2019

Source: https://www.keypedia.com/records/483/avera-mckennan-hospital-irb-1-dba-avera-irb-1/07b67787-a564-4871-9128-0dc0b9fe48d1

> FDA 483 for Avera McKennan Hospital IRB #1 DBA Avera IRB #1 on July 10, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Avera McKennan Hospital IRB #1 DBA Avera IRB #1
- Inspection Date: 2019-07-10
- Product Type: other
- Office Name: Minneapolis District Office
- Summary: Avera McKennan Hospital IRB #1 DBA Avera IRB #1 in Sioux Falls, SD, received a Form 483 for multiple deficiencies in its Institutional Review Board operations. Key issues include failures in meeting quorum requirements, inadequate meeting minutes, non-adherence to written procedures for research review and roster management, and insufficient record-keeping. These findings indicate significant non-compliance with regulatory requirements for IRB oversight of FDA-regulated research.

## Related Documents

- [483 - 2018-07-26](https://www.keypedia.com/records/483/avera-mckennan-hospital-irb-1-dba-avera-irb-1/382b47ae-9da0-4b34-bb7c-f9fc754b0cc2)

## Related Officers

- [investigator](https://www.keypedia.com/people/nicole-c-victoria/8c5f8060-452f-4fe5-a43f-a448ec020e60)

Company: https://www.keypedia.com/companies/avera-mckennan-hospital-irb-1-dba-avera-irb-1/35301d84-ada6-41b5-8a13-a5068de3ef30

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