# FDA 483 - Samer Kazziha MD - July 31, 2020

Source: https://www.keypedia.com/records/483/samer-kazziha-md/d6ec4983-464a-4cab-9aa6-a3cfda6e6096

> FDA 483 for Samer Kazziha MD on July 31, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Samer Kazziha MD
- Inspection Date: 2020-07-31
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Samer Kazziha MD, a clinical investigator in Sterling Heights, MI, was cited for significant deficiencies related to an investigational trial. The inspection revealed failures in ensuring research participants received critical study updates and new risk information, as well as a failure to report a study hold to the Institutional Review Board (IRB). These issues indicate a lack of adherence to the investigational plan and IRB requirements.

## Related Officers

- [Andrace Deyampert](https://www.keypedia.com/people/andrace-deyampert/cdb4f833-488b-42b9-abab-4216435bce4c)

Company: https://www.keypedia.com/companies/samer-kazziha-md/cd5b8cfb-186e-42bf-b6aa-db0b3e9e5a71

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