# FDA 483 - Sigrid Blome-Eberwein - September 28, 2020

Source: https://www.globalkeysolutions.net/records/483/sigrid-blome-eberwein/93b6e9ca-bf1b-4986-b3bd-9af1eefb1312

> FDA 483 for Sigrid Blome-Eberwein on September 28, 2020. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sigrid Blome-Eberwein
- Inspection Date: 2020-09-28
- Product Type: other
- Office Name: Philadelphia District Office
- Summary: Sigrid Blome-Eberwein, MD, a Clinical Investigator in Allentown, PA, was issued a Form 483 following an FDA inspection from September 10-28, 2020. The inspection revealed that an investigation was not conducted in accordance with the investigational plan. Specifically, issues were noted with the recording of information for subjects randomized to a standard of care.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/kelly-n-kerr/6f9e1ba0-61ca-403d-a337-9efece792c21)

Company: https://www.globalkeysolutions.net/companies/sigrid-blome-eberwein/7efd97a7-6982-4a59-a9d8-dfad5cf422d1

Office: https://www.globalkeysolutions.net/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8