# FDA 483 - Guenther Koehne, M.D. - January 10, 2024

Source: https://www.keypedia.com/records/483/guenther-koehne-md/3e472d7a-a834-48b4-ab6d-b1540efccf33

> FDA 483 for Guenther Koehne, M.D. on January 10, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Guenther Koehne, M.D.
- Inspection Date: 2024-01-10
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Guenther Koehne, M.D. at Miami Cancer Institute revealed significant deviations in the conduct of a clinical investigation. The firm failed to follow the investigational plan, specifically by not reporting serious adverse events for multiple subjects and enrolling more subjects than permitted by the study protocol. These findings indicate serious non-compliance with clinical trial regulations.

## Related Officers

- [Richard A. Lyght](https://www.keypedia.com/people/richard-a-lyght/8d60b5c0-4acd-4abc-979a-fb4b3e82964d)

Company: https://www.keypedia.com/companies/guenther-koehne-md/9b80e6a1-94a8-41ee-8788-62e9c2f3717b

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6