# FDA 483 - Opada Alzohaili, M.D. - August 14, 2013

Source: https://www.keypedia.com/records/483/opada-alzohaili-md/a5818699-b9bf-4c9f-a40f-1bba74ff1f97

> FDA 483 for Opada Alzohaili, M.D. on August 14, 2013. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Opada Alzohaili, M.D.
- Inspection Date: 2013-08-14
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Opada Alzohaili, M.D. in Dearborn, MI, was cited for significant deficiencies in conducting a clinical investigation. The inspection revealed failures in adhering to the investigational plan, including delays in subject rescue/dose titration, improper investigational product administration and storage, and incomplete safety assessments. Additionally, the firm failed to obtain proper informed consent, maintain accurate case histories, and retain investigational records as required.

## Related Documents

- [483 - 2016-03-29](https://www.keypedia.com/records/483/opada-alzohaili-md/c6f65afc-bb02-402b-a089-ddf758f07cac)

## Related Officers

- [L'Oreal F. Walker](https://www.keypedia.com/people/loreal-f-walker/54e821e1-4646-499e-91f1-a6b37214cb7c)

Company: https://www.keypedia.com/companies/opada-alzohaili-md/d50daa52-079f-4319-af28-d2f3442df575

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0