# FDA 483 - Indiana Orthopaedic Hospital, LLC IRB #1 - February 13, 2019

Source: https://www.keypedia.com/records/483/indiana-orthopaedic-hospital-llc-irb-1/f5bdd97c-62ca-457f-9bff-a196f5fbf56f

> FDA 483 for Indiana Orthopaedic Hospital, LLC IRB #1 on February 13, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Indiana Orthopaedic Hospital, LLC IRB #1
- Inspection Date: 2019-02-13
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Indiana Orthopaedic Hospital, LLC IRB #1 in Indianapolis, IN, revealed significant deficiencies in its Institutional Review Board (IRB) operations. The IRB failed to properly advise members of expedited approvals, lacked a nonscientific member, did not conduct timely continuing reviews, and failed to report study suspensions to the FDA. These issues indicate a lack of adherence to regulatory requirements for IRB oversight.

## Related Documents

- [483 - 2019-02-13](https://www.keypedia.com/records/483/indiana-orthopaedic-hospital-llc-irb-1/64d16084-837c-45e6-90c3-d3fb540a71e6)

## Related Officers

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

Company: https://www.keypedia.com/companies/indiana-orthopaedic-hospital-llc-irb-1/6648c8dd-ed28-4d64-995e-e73dd1403e57

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