# FDA 483 - Wheeling Hospital IRB - April 12, 2022

Source: https://www.keypedia.com/records/483/wheeling-hospital-irb/c9349e34-f77f-4f96-ae30-9d17e2de712c

> FDA 483 for Wheeling Hospital IRB on April 12, 2022. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Wheeling Hospital IRB
- Inspection Date: 2022-04-12
- Product Type: other
- Office Name: Office of Regulatory Affairs
- Summary: This FDA Form 483 details significant deficiencies at Wheeling Hospital IRB related to its oversight of human subject research. Observations include failures to maintain proper quorum during convened meetings and inadequate detail in meeting minutes regarding attendance, actions, and voting. Furthermore, the IRB did not follow its own procedures for managing expired studies and lacked written procedures for promptly reporting serious noncompliance or suspension/termination of approvals to the FDA.

## Related Officers

- [Cynthia L. Rakestraw](https://www.keypedia.com/people/cynthia-l-rakestraw/ca138abf-e5d4-43ca-b9d2-79ea6294a8c8)

Company: https://www.keypedia.com/companies/wheeling-hospital-irb/3623b744-0c56-4d56-adac-a0c0e37d3b20

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64