# FDA 483 - Centra Health Inc IRB - September 14, 2009

Source: https://www.keypedia.com/records/483/centra-health-inc-irb/f8881224-9fa9-4571-9c5a-3b7bd022a9a3

> FDA 483 for Centra Health Inc IRB on September 14, 2009. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Centra Health Inc IRB
- Inspection Date: 2009-09-14
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: Centra Health Inc IRB in Lynchburg, VA, was cited for numerous deficiencies in its Institutional Review Board Policy and Procedure Manual, last reviewed in January 2000. Key issues include the absence of written procedures for initial and continuing review, reporting suspensions, unanticipated problems, and noncompliance, as well as failures in maintaining detailed meeting minutes and managing conflicts of interest. The inspection revealed systemic procedural gaps impacting the oversight and approval of research studies involving human subjects.

## Related Officers

- [investigator](https://www.keypedia.com/people/brian-r-yaun/9be73cb9-f46e-40e6-a43e-f9d09109ba7d)

Company: https://www.keypedia.com/companies/centra-health-inc-irb/cc9763d3-77b2-42d0-8195-049dede2d471

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e