# FDA 483 - Creighton University IRB - April 07, 2022

Source: https://www.keypedia.com/records/483/creighton-university-irb/2d96f07d-f171-4d2a-8e03-1ddf5fec9134

> FDA 483 for Creighton University IRB on April 07, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Creighton University IRB
- Inspection Date: 2022-04-07
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Creighton University IRB in Omaha, NE, revealed significant deficiencies across multiple areas of its operations. The firm failed to maintain required records for three years post-research completion and did not follow its own written procedures for reviewing research. Additionally, meeting minutes were found to be insufficiently detailed, lacking crucial information regarding attendance, actions, and voting records.

## Related Officers

- [Theressa B. Smith](https://www.keypedia.com/people/theressa-b-smith/80f0c339-7eac-4c73-b9f6-ecb368738fe6)

Company: https://www.keypedia.com/companies/creighton-university-irb/d88797ef-211c-4c3e-a162-bccbcf9ca641

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