# FDA 483 - Prof. Thomas Zeller, M.D. - May 25, 2018

Source: https://www.globalkeysolutions.net/records/483/prof-thomas-zeller-md/9412672f-becf-4cb2-ab92-bb55765dba8e

> FDA 483 for Prof. Thomas Zeller, M.D. on May 25, 2018. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Prof. Thomas Zeller, M.D.
- Inspection Date: 2018-05-25
- Product Type: other
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Prof. Thomas Zeller, M.D., a clinical investigator in Bad Krozingen, Germany, revealed significant deviations from the investigational plan. The inspection found that subjects were enrolled who did not meet protocol criteria and that a serious adverse event was not reported to the sponsor within the required timeframe. These findings indicate a failure to adhere to study protocols and regulatory expectations for clinical investigations.

## Related Officers

- [Bioresearch Monitoring Foreign Inspection Cadre Member](https://www.globalkeysolutions.net/people/richard-w-berning/4637e321-8803-4fcf-911f-bbc810c3487d)

Company: https://www.globalkeysolutions.net/companies/prof-thomas-zeller-md/e4c2e75f-ebe7-47fe-9a54-f00fd3f97006

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd