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

Source: https://www.keypedia.com/records/483/indiana-orthopaedic-hospital-llc-irb-1/64d16084-837c-45e6-90c3-d3fb540a71e6

> FDA 483 for Indiana Orthopaedic Hospital, LLC IRB #1 on February 13, 2019. Product: devices. 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: devices
- Office Name: Detroit District Office
- Summary: During an FDA inspection conducted from February 1 to February 13, 2019, at Indiana Orthopaedic Hospital, LLC IRB #1, several significant observations were noted regarding its operations as an Institutional Review Board. The inspection, issued to Edward J. Hellman, M.D., MBA, IRB Co-Chair, highlighted four key areas of concern. First, the IRB did not adequately inform all members about research proposals approved via expedited review, specifically regarding temporary investigational device implantations for IRB Study #0145 that were not explicitly covered in informed consent. Second, the IRB lacked a nonscientific member during the annual continuing review of IRB Study #0087, which is a key compositional requirement. Third, the facility did not consistently conduct continuing review of research at intervals of not less than once per year, evidenced by a six-day lapse for IRB Study #0145. Finally, the IRB lacked written procedures for the prompt reporting of suspended or terminated study approvals to the FDA, failing to notify the agency when IRB Study #0145 was suspended. These observations indicate areas where the IRB’s practices did not align with regulatory expectations for human subject protection and IRB oversight under the Federal Food, Drug, and Cosmetic Act. The company is expected to address these findings and implement corrective actions.

## Related Documents

- [483 - 2019-02-13](https://www.keypedia.com/records/483/indiana-orthopaedic-hospital-llc-irb-1/f5bdd97c-62ca-457f-9bff-a196f5fbf56f)

## 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/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03