# FDA 483 - Wayne M. Clark, MD - October 27, 2023

Source: https://www.keypedia.com/records/483/wayne-m-clark-md/09071426-fd33-4c82-8c48-569119ae2fa9

> FDA 483 for Wayne M. Clark, MD on October 27, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wayne M. Clark, MD
- Inspection Date: 2023-10-27
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of Wayne M. Clark, MD, Clinical Investigator in Portland, OR, revealed two significant observations. The inspection found that the clinical investigation was not conducted according to the investigational plan and applicable FDA regulations, specifically regarding the blinding of study team members. Additionally, records of subject case histories were found to be inaccurate, impacting data integrity.

## Related Officers

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

Company: https://www.keypedia.com/companies/wayne-m-clark-md/afd98d7e-b7db-4882-b0b6-3cc5e38b14f1

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