# FDA 483 - Michael Lissy, M.D. - May 09, 2025

Source: https://www.keypedia.com/records/483/michael-lissy-md/fe273ca0-6126-42e9-b465-20e22cb8a327

> FDA 483 for Michael Lissy, M.D. on May 09, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Michael Lissy, M.D.
- Inspection Date: 2025-05-09
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Michael Lissy, M.D., a clinical investigator in Neu-Ulm, Bavaria, revealed a failure to prepare or maintain adequate case histories for a study protocol. Specifically, issues included the destruction of sealed code break emergency envelopes before verification and a lack of documentation regarding subject positioning for vital sign measurements as required by the protocol. These deficiencies indicate significant concerns with data integrity and adherence to study protocols.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/karen-m-montgomery/ee91b1bb-8d51-4fdc-bee5-949441136e59)

Company: https://www.keypedia.com/companies/michael-lissy-md/00203348-d0ad-49a3-a49d-6c54f6e9f834

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