# FDA 483 - Hagen F. Kennecke, M.D. - May 02, 2024

Source: https://www.globalkeysolutions.net/records/483/hagen-f-kennecke-md/6921252a-5125-4b27-9e38-0c325f0e5792

> FDA 483 for Hagen F. Kennecke, M.D. on May 02, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hagen F. Kennecke, M.D.
- Inspection Date: 2024-05-02
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Hagen F. Kennecke, M.D., a clinical investigator in Portland, OR, was cited for significant deviations from protocol and regulatory requirements during a clinical study. The inspection revealed failures to manage subject safety, including not interrupting study drug dosing or referring a subject to an ophthalmologist despite severe ocular toxicity, and not reporting an adverse event. Additionally, the firm failed to obtain proper informed consent documentation for a study subject.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/hagen-f-kennecke-md/a4de6c61-b7fd-4ede-bf0b-4642a4036883

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