# FDA 483 - Muhammad Salman Ali Ashraf - May 16, 2019

Source: https://www.keypedia.com/records/483/muhammad-salman-ali-ashraf/18e219e6-f80e-4f2b-84ac-d3ec9c59d226

> FDA 483 for Muhammad Salman Ali Ashraf on May 16, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Muhammad Salman Ali Ashraf
- Inspection Date: 2019-05-16
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Muhammad Salman Ali Ashraf, a clinical investigator in Springfield, OH, revealed significant deficiencies in the conduct of a clinical study. Observations included a lapse in IRB approval, failure to obtain informed consent from a majority of subjects, and multiple deviations from the investigational plan regarding screening labs, inclusion criteria, and adverse event reporting. These findings indicate serious non-compliance with regulatory requirements for human subject protection and clinical trial conduct.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/kathryn-l-suttling/2d4695ca-5ec3-4658-8f46-101cec4ca41d)

Company: https://www.keypedia.com/companies/muhammad-salman-ali-ashraf/ab6eb8e0-e6a4-4016-8806-55e576621f2a

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