# FDA 483 - MercyOne North Iowa Medical Center IRB - June 21, 2019

Source: https://www.globalkeysolutions.net/records/483/mercyone-north-iowa-medical-center-irb/a5e452e1-6325-453b-8d5c-b909b61f0f82

> FDA 483 for MercyOne North Iowa Medical Center IRB on June 21, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MercyOne North Iowa Medical Center IRB
- Inspection Date: 2019-06-21
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of MercyOne North Iowa Medical Center IRB in Mason City, IA, revealed significant deficiencies in its Institutional Review Board operations. The firm failed to maintain required records for three years, did not promptly notify investigators in writing of research approvals or modifications, and prepared meeting minutes lacking sufficient detail regarding attendance and voting. These issues indicate a lack of adherence to regulatory requirements for IRB recordkeeping and communication.

## Related Documents

- [483 - 2019-06-21](https://www.globalkeysolutions.net/records/483/mercyone-north-iowa-medical-center-irb/9592a4d6-f048-4e60-a66d-f18872bedd90)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/shalonda-clifford/b6d67ba0-e40e-4347-9b58-a2bddc6983e3)

Company: https://www.globalkeysolutions.net/companies/mercyone-north-iowa-medical-center-irb/11d8e28b-6d08-47e0-b865-08403f58e237

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8