# FDA 483 - David Scott - March 24, 2010

Source: https://www.keypedia.com/records/483/david-scott/4e96ebe2-99e2-4c37-a3a1-e6d2476d6c94

> FDA 483 for David Scott on March 24, 2010. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: David Scott
- Inspection Date: 2010-03-24
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of David F. Scott, M.D., Clinical Investigator in Spokane, WA, revealed multiple significant deviations from clinical trial protocols and regulatory requirements. The firm failed to ensure subjects met inclusion/exclusion criteria, did not perform required laboratory tests and physical examinations, and conducted study procedures before obtaining informed consent. Additionally, the inspection found issues with unapproved changes to research activities, inadequate case histories, and insufficient investigational drug disposition records.

## Related Officers

- [S. Lori Brown, PhD, MPH, Investigator](https://www.keypedia.com/people/s-lori-brown-phd-mph-investigator/4c581d6f-ab8c-4a54-9350-fb8fe466cbe1)
- [Sunitha K. Rajaram, PhD, Investigator](https://www.keypedia.com/people/sunitha-k-rajaram-phd-investigator/aaee6ca6-a503-4ce8-8d4e-37919fa8ffc7)

Company: https://www.keypedia.com/companies/david-scott/f7cdc60c-12a0-41f7-8cef-60ce4446c9b7

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