# FDA 483 - Agnesian Healthcare IRB - June 17, 2014

Source: https://www.globalkeysolutions.net/records/483/agnesian-healthcare-irb/0539a462-475d-42f8-a018-c915f1409044

> FDA 483 for Agnesian Healthcare IRB on June 17, 2014. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Agnesian Healthcare IRB
- Inspection Date: 2014-06-17
- Product Type: other
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Agnesian Healthcare IRB in Fond Du Lac, WI, revealed significant deficiencies in its Institutional Review Board operations. The firm failed to promptly notify investigators of research decisions, maintain complete correspondence records, and prepare detailed meeting minutes. These observations highlight systemic issues in the IRB's record-keeping and communication practices.

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Company: https://www.globalkeysolutions.net/companies/agnesian-healthcare-irb/ccc2128b-cff1-4956-943c-826172ca8b1b

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