# FDA 483 - William J. Gradishar, M.D. - February 28, 2020

Source: https://www.globalkeysolutions.net/records/483/william-j-gradishar-md/2f0a5697-f794-4895-9e5f-a07182c4cdb5

> FDA 483 for William J. Gradishar, M.D. on February 28, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: William J. Gradishar, M.D.
- Inspection Date: 2020-02-28
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: William J. Gradishar, M.D., a clinical investigator in Chicago, IL, was cited for two observations during an FDA inspection. The inspection revealed that an investigation was not conducted in accordance with the investigational plan, specifically regarding disease progression criteria and inclusion criteria documentation. Additionally, the firm failed to prepare or maintain adequate case histories, including missing test article accountability logs and source documentation for subject deaths.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/shalonda-clifford/b6d67ba0-e40e-4347-9b58-a2bddc6983e3)
- [issuing_officer](https://www.globalkeysolutions.net/people/jennifer-c-adams/85608566-bd13-41d8-b86e-cc9111c7dfe5)

Company: https://www.globalkeysolutions.net/companies/william-j-gradishar-md/066cf0b5-4144-4bc2-a3da-88cfb7e61979

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669