# FDA 483 - Opada Alzohaili, M.D. - March 29, 2016

Source: https://www.keypedia.com/records/483/opada-alzohaili-md/c6f65afc-bb02-402b-a089-ddf758f07cac

> FDA 483 for Opada Alzohaili, M.D. on March 29, 2016. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Opada Alzohaili, M.D.
- Inspection Date: 2016-03-29
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Opada AlZohaili, M.D., a clinical investigator in Dearborn, MI, revealed two significant observations. The firm failed to properly document informed consent, specifically by not having subjects date consent forms. Additionally, the firm did not maintain adequate and accurate case histories, with discrepancies noted between electronic medical records and study team notes regarding subject inclusion criteria.

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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