# FDA 483 - Indiana University IRB - February 14, 2020

Source: https://www.globalkeysolutions.net/records/483/indiana-university-irb/c80d1bca-7fa1-4557-bd30-8ab87a619505

> FDA 483 for Indiana University IRB on February 14, 2020. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Indiana University IRB
- Inspection Date: 2020-02-14
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Indiana University IRB in Indianapolis, IN, conducted from February 6-14, 2020, identified a significant procedural deficiency. The Institutional Review Board failed to report research proposals approved under expedited review procedures back to the full board. This practice deviates from the IRB's own written procedures, indicating a lapse in oversight.

## Related Documents

- [483 - 2020-02-14](https://www.globalkeysolutions.net/records/483/indiana-university-irb/7f9e3ad4-2ee8-4831-87bb-0bb09738b671)

## Related Officers

- [U.S. Food and Drug Administration](https://www.globalkeysolutions.net/people/myra-k-casey/a2fae714-2ba3-4c60-9f54-990fc7b169c9)

Company: https://www.globalkeysolutions.net/companies/indiana-university-irb/2301cc8b-f27f-4093-a475-a5991634ce47

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0