# FDA 483 - Nebraska Methodist Hospital IRB - June 12, 2025

Source: https://www.globalkeysolutions.net/records/483/nebraska-methodist-hospital-irb/d12512b2-cdc4-423e-8337-2a4e28ff3a18

> FDA 483 for Nebraska Methodist Hospital IRB on June 12, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nebraska Methodist Hospital IRB
- Inspection Date: 2025-06-12
- Product Type: other
- Office Name: Kansas City District Office
- Summary: The FDA inspected Nebraska Methodist Hospital IRB in Omaha, NE, and identified four significant issues. These issues primarily concern the IRB's failure to maintain accurate records, including membership rosters and detailed meeting minutes, and non-compliance with meeting quorum requirements and timely registration updates. The findings indicate deficiencies in the IRB's oversight of clinical research.

## Related Officers

- [Logan M. Jones](https://www.globalkeysolutions.net/people/logan-m-jones/286ab813-461a-4bfc-a732-bcd4f0d6e596)

Company: https://www.globalkeysolutions.net/companies/nebraska-methodist-hospital-irb/89cf356a-b082-4ec3-bf11-c047da2c6e79

Office: https://www.globalkeysolutions.net/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79
