# Marian E. Shaw, MD – FDA 483, Jan 27, 2025

Source: https://www.keypedia.com/records/483/marian-e-shaw-md/75b0b09e-9a3e-4eaa-ab92-5cd4e704cbd4

> FDA 483 for Marian E. Shaw, MD on January 27, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Marian E. Shaw, MD
- Inspection Date: 2025-01-27
- Product Type: drugs
- Office Name: Seattle District Office
- Summary: An FDA inspection of Marian E. Shaw, MD, a clinical investigator for Novavax, Inc., revealed significant deficiencies in the conduct of a clinical trial. Observations included failures to maintain adequate case histories by not verifying subject eligibility with medical records, relying instead on verbal confirmation. Additionally, the investigator administered study materials after a temperature excursion without prior sponsor approval and failed to obtain Institutional Review Board approval for these protocol deviations.

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Company: https://www.keypedia.com/companies/marian-e-shaw-md/abc5a42b-8bf6-411f-9f1e-6f7fa646f67a

Office: https://www.keypedia.com/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913