# FDA 483 - James W. Baker, MD - June 19, 2017

Source: https://www.globalkeysolutions.net/records/483/james-w-baker-md/95066e8f-1a4b-43d8-892f-c4b0b2377333

> FDA 483 for James W. Baker, MD on June 19, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: James W. Baker, MD
- Inspection Date: 2017-06-19
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: James W. Baker, MD, a clinical investigator in Portland, OR, was cited for significant deficiencies in clinical trial conduct. The inspection revealed failures in maintaining accurate case histories, non-adherence to investigational plans, and inadequate informed consent processes, particularly concerning pediatric subjects. These issues indicate a serious lack of oversight and compliance with regulatory requirements for human subject protection and data integrity.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/james-w-baker-md/bb82a696-8526-4bfd-bbcb-b1b46f50065b

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