# FDA 483 - Ines Guttmann-Bauman MD - December 12, 2019

Source: https://www.keypedia.com/records/483/ines-guttmann-bauman-md/f9e9d07c-1c06-46da-b91a-62cc0d262dca

> FDA 483 for Ines Guttmann-Bauman MD on December 12, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ines Guttmann-Bauman MD
- Inspection Date: 2019-12-12
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of Ines Guttmann-Bauman, MD, a clinical investigator in Portland, OR, revealed significant deficiencies in the conduct of an investigational study. Observations included failure to follow the investigational plan, specifically regarding subject screening, laboratory result review, and proper informed consent documentation. Additionally, the firm failed to maintain adequate and accurate case histories for the investigation.

## Related Officers

- [Julian C. Hanson](https://www.keypedia.com/people/julian-c-hanson/489e27d9-0de6-4bf0-8aec-e5d500841f52)

Company: https://www.keypedia.com/companies/ines-guttmann-bauman-md/25caf8ae-6b80-492a-a5cd-3b2b25f4ac72

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