# FDA 483 - Raed Alalawi, M.D. - June 10, 2021

Source: https://www.keypedia.com/records/483/raed-alalawi-md/d64fc342-2d75-4709-9650-3ccc267458b7

> FDA 483 for Raed Alalawi, M.D. on June 10, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Raed Alalawi, M.D.
- Inspection Date: 2021-06-10
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of Raed Alalawi, M.D. in Phoenix, AZ, identified significant issues with the conduct of a clinical investigation. The firm failed to conduct the investigation in accordance with the signed statement of investigator and investigational plan, specifically regarding investigator-specific assessments. Additionally, there was inadequate oversight, leading to a clinical coordinator performing investigator assessments and subsequent deletion of source data.

## Related Officers

- [Iris C. Macinnes](https://www.keypedia.com/people/iris-c-macinnes/5e8d7fef-18d5-453d-82b2-19e8e2897d26)

Company: https://www.keypedia.com/companies/raed-alalawi-md/5d811093-c088-4b1f-93f5-78c611aa1575

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face