# FDA 483 - Mayo Clinic IRB - April 28, 2017

Source: https://www.keypedia.com/records/483/mayo-clinic-irb/e260293c-069c-40eb-b8ee-b23abdfa3d6c

> FDA 483 for Mayo Clinic IRB on April 28, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mayo Clinic IRB
- Inspection Date: 2017-04-28
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: During an inspection conducted from April 24 to April 28, 2017, the FDA issued a Form 483 to the Mayo Clinic IRB. The inspection, focusing on Bioresearch Monitoring (BIMO) for Institutional Review Boards, identified two primary observations indicating non-compliance with regulatory expectations. The firm, located in Rochester, MN, was inspected regarding its oversight of human subject research. Firstly, the inspection revealed that minutes from IRB meetings lacked sufficient detail regarding member attendance and voting outcomes. Specifically, the firm's own procedures for documenting votes were not consistently followed in 4 out of 12 reviewed meeting minutes. Examples included discrepancies where the number of votes tallied did not match the number of voting members present, without adequate explanation for the difference. Secondly, the FDA observed instances where clinical investigators failed to report the emergency use of test articles to the IRB within the mandated five-day timeframe. Five out of twenty-seven reviewed emergency uses were reported beyond this regulatory window, with delays ranging from several days to over a year. These observations highlight areas where the Mayo Clinic IRB needs to enhance its documentation practices for meeting minutes and improve the timeliness of reporting emergency test article uses, ensuring adherence to its internal procedures and regulatory requirements for the oversight of human subject research. The facility is expected to address these findings and implement corrective actions.

## Related Officers

- [Medical Director of IRB Chairs](https://www.keypedia.com/people/dr-r-scott-wright/b0be41fd-f4b2-42c0-ba6f-d1bb4e94ce55)
- [investigator](https://www.keypedia.com/people/corey-k-reno/f6ff7629-784b-467b-8b5b-2625779d1c1e)

Company: https://www.keypedia.com/companies/mayo-clinic-irb/f175ee12-bdf2-494f-936e-a0dbe6cc1513

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