# FDA 483 - Roman Skoracki MD - February 28, 2020

Source: https://www.keypedia.com/records/483/roman-skoracki-md/de14215c-1b25-4c9d-a364-1825c8531409

> FDA 483 for Roman Skoracki MD on February 28, 2020. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Roman Skoracki MD
- Inspection Date: 2020-02-28
- Product Type: other
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Roman Skoracki MD in Columbus, OH, identified a significant issue related to the conduct of an investigational plan. The firm failed to ensure that assessments were performed by qualified personnel as instructed in the protocol and that personnel were properly listed in the delegation of authority log. This indicates a lack of adherence to study protocols and proper oversight in clinical research.

## Related Officers

- [investigator](https://www.keypedia.com/people/craig-t-rybus/246aad79-6370-42e2-af6e-c0079c1bcbc6)

Company: https://www.keypedia.com/companies/roman-skoracki-md/2613bb9d-521f-4582-8ab3-74f40ba2dcb3

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22