# FDA 483 - Evan Alley, M.D., Ph.D. - September 05, 2019

Source: https://www.keypedia.com/records/483/evan-alley-md-phd/2909eda3-98ab-448d-9b80-a8b34932d365

> FDA 483 for Evan Alley, M.D., Ph.D. on September 05, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Evan Alley, M.D., Ph.D.
- Inspection Date: 2019-09-05
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Evan Alley, M.D., Ph.D. in Philadelphia revealed a significant deviation from the investigational plan and protocol. The principal investigator failed to obtain confirmation from the blinded independent committee review (BICR) for disease progression before discontinuing subjects from study treatment. This lapse occurred in multiple instances, indicating a failure to adhere to critical study procedures.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/anastasia-offordile/299aed81-16f8-413e-a318-2d7f741957da)

Company: https://www.keypedia.com/companies/evan-alley-md-phd/1c6729dd-58e2-4224-9a67-13bb38c52743

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