# FDA 483 - Dakhil, Dr Shaker - May 10, 2021

Source: https://www.globalkeysolutions.net/records/483/dakhil-dr-shaker/9d5f158c-86ce-4bcb-bc53-e2a61cc6bf22

> FDA 483 for Dakhil, Dr Shaker on May 10, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dakhil, Dr Shaker
- Inspection Date: 2021-05-10
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Shaker R. Dakhil, MD, a clinical investigator in Wichita, KS, revealed two significant observations. The firm failed to conduct an investigation in accordance with the investigational plan, specifically regarding documentation of investigational product dosing and timely reporting of a serious adverse event. Additionally, the firm did not maintain adequate case histories, as several adverse events were not reported in the electronic case report forms.

## Related Officers

- [Byungja E. Marciante](https://www.globalkeysolutions.net/people/byungja-e-marciante/5d1f2927-9017-4ab6-8ad2-521e340ef14f)

Company: https://www.globalkeysolutions.net/companies/dakhil-dr-shaker/ff880691-4af7-4e7b-ac3d-7c9c33c6bc2a

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8