# FDA 483 - Mark A. Stein, Ph.D. - August 04, 2023

Source: https://www.globalkeysolutions.net/records/483/mark-a-stein-phd/d415ba7c-e7f9-4fa9-b833-2f07bb57bfbb

> FDA 483 for Mark A. Stein, Ph.D. on August 04, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mark A. Stein, Ph.D.
- Inspection Date: 2023-08-04
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Mark A. Stein, Ph.D., a clinical investigator in Seattle, WA, was cited for significant deviations during human clinical studies. The inspection revealed failures to adhere to investigational plans and study protocols, including enrolling ineligible subjects, improper drug dosing, and not conducting required safety and efficacy assessments. Additionally, the firm failed to maintain adequate and accurate case histories, exhibiting discrepant data, unreported adverse events, and unattributable or unexplained record changes.

## Related Officers

- [Veronica L. Bush](https://www.globalkeysolutions.net/people/veronica-l-bush/3582dd62-2cdf-4d1d-a78b-305c908ef9d5)
- [investigator](https://www.globalkeysolutions.net/people/sherri-n-rohlf/41090ab1-83d1-4e95-92ea-0cfca5cecdb6)

Company: https://www.globalkeysolutions.net/companies/mark-a-stein-phd/77ed667b-2b69-476d-b6f5-fafc47ef8df0

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