# FDA 483 - WCG IRB, Inc - August 24, 2018

Source: https://www.keypedia.com/records/483/wcg-irb-inc/37dc111c-d7d9-4d06-b1c3-54d0eb7420c0

> FDA 483 for WCG IRB, Inc on August 24, 2018. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: WCG IRB, Inc
- Inspection Date: 2018-08-24
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of Western Institutional Review Board Inc in Puyallup, WA, revealed a significant issue with informed consent documents. The IRB approved forms for an investigational device study inaccurately stated that the device's safety had been tested and proven, failing to adequately describe experimental procedures. This indicates a serious concern regarding the protection of human subjects in clinical trials.

## Related Officers

- [investigator](https://www.keypedia.com/people/sherri-n-rohlf/41090ab1-83d1-4e95-92ea-0cfca5cecdb6)

Company: https://www.keypedia.com/companies/wcg-irb-inc/f755e1b3-f395-409e-99c5-4374ae81366f

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822