# FDA 483 - Leonard Appleman, M.D, PhD - June 14, 2021

Source: https://www.keypedia.com/records/483/leonard-appleman-md-phd/fd2f1b31-9c65-4a36-8752-c2991c54b494

> FDA 483 for Leonard Appleman, M.D, PhD on June 14, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Leonard Appleman, M.D, PhD
- Inspection Date: 2021-06-14
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: Leonard Appleman, M.D, PhD, a clinical investigator in Pittsburgh, PA, was cited for significant deficiencies during an FDA inspection. The inspection revealed failures to conduct an investigation according to the signed statement and investigational plan, including issues with reporting serious and non-serious adverse events and concomitant medications. Additionally, the firm failed to maintain adequate and accurate case histories, specifically regarding the reporting of the primary study endpoint.

## Related Officers

- [Cynthia L. Rakestraw](https://www.keypedia.com/people/cynthia-l-rakestraw/ca138abf-e5d4-43ca-b9d2-79ea6294a8c8)

Company: https://www.keypedia.com/companies/leonard-appleman-md-phd/575b0d77-7832-4887-90bf-63df50d454a1

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