# FDA 483 - Western Reserve Health Education IRB - November 20, 2019

Source: https://www.keypedia.com/records/483/western-reserve-health-education-irb/18abcd6f-c6af-4c7e-9d95-44cdf7712b7b

> FDA 483 for Western Reserve Health Education IRB on November 20, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Western Reserve Health Education IRB
- Inspection Date: 2019-11-20
- Product Type: other
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Western Reserve Health Education IRB in Youngstown, OH, revealed significant deficiencies in its oversight of clinical research. The firm failed to ensure informed consent documents adequately described risks and procedures, and its Institutional Review Board (IRB) operations exhibited multiple issues. These included improper meeting conduct, insufficient documentation of meeting minutes, and non-adherence to its own written procedures for research review and membership management.

## Related Officers

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

Company: https://www.keypedia.com/companies/western-reserve-health-education-irb/094f38bb-1449-4e67-ad7e-1ab48eb82342

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22