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

Source: https://www.keypedia.com/records/483/samer-kazziha-md/ba64905c-f846-456e-a5c0-aea27a965035

> 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: Detroit District Office
- Summary: An FDA Form 483 was issued to Samer Kazziha MD, a Clinical Investigator in Sterling Heights, MI, following an inspection conducted from July 13 to July 31, 2020. The inspection revealed significant deviations from the investigational plan, primarily concerning participant safety and informed consent processes in an investigational trial. The primary observation noted that the investigation was not conducted according to its approved plan. Specifically, over 50% of enrolled research participants were not adequately informed of critical study updates. This included new risks, an extended study participation period, revised information on alternative treatments, and potential harm to an unborn child. These omissions directly contravened the protocol's requirement that patients be fully informed and consent freely, and specific instructions from the Institutional Review Board (IRB). Furthermore, the clinical investigator failed to report a study hold to the IRB. The sponsor had initiated this hold on screening and enrollment in March 2018 due to significant site issues and explicitly instructed the investigator to inform the IRB. This constitutes a failure to adhere to IRB requirements as stipulated in the investigational plan. These observations highlight concerns regarding patient protection and adherence to clinical trial protocols, falling under the regulatory purview of the Federal Food, Drug, and Cosmetic Act. Samer Kazziha MD is expected to respond to these observations with proposed corrective actions to ensure future compliance and safeguard research participants.

## Related Documents

- [483 - 2020-07-31](https://www.keypedia.com/records/483/samer-kazziha-md/d6ec4983-464a-4cab-9aa6-a3cfda6e6096)

## 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/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03