# FDA 483 - Seth M.Pollack, M.D. - June 27, 2019

Source: https://www.keypedia.com/records/483/seth-mpollack-md/4d63d499-396f-418e-a39e-77334aea3480

> FDA 483 for Seth M.Pollack, M.D. on June 27, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Seth M.Pollack, M.D.
- Inspection Date: 2019-06-27
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of Fred Hutchinson Cancer Research Center in Seattle, WA, identified multiple significant deviations in the conduct of a clinical investigation. Key issues included enrolling ineligible subjects, failing to properly re-consent participants, not adhering to protocol-specified procedures, and deficiencies in IRB review and approval processes for informed consent documents and Investigator Brochures. These findings highlight critical lapses in clinical trial oversight and subject protection.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/sunitha-k-rajaram/1a0872d4-5e7b-4690-a2be-3877aec25053)

Company: https://www.keypedia.com/companies/seth-mpollack-md/78b93ab0-bd53-480b-b992-fd62c663a8d3

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