# FDA 483 - Sabine S. Hazan, M.D. - September 21, 2021

Source: https://www.keypedia.com/records/483/sabine-s-hazan-md/39446c29-f9a6-4ae7-9723-6b8c558fe6b9

> FDA 483 for Sabine S. Hazan, M.D. on September 21, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sabine S. Hazan, M.D.
- Inspection Date: 2021-09-21
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Sabine S. Hazan, M.D., a clinical investigator in Ventura, CA, was cited for significant deficiencies during an FDA inspection related to an investigational new drug (IND) study. Observations included failure to adhere to the investigational plan by enrolling ineligible subjects and not performing required screenings, continuing a study without active Institutional Review Board (IRB) approval, and administering investigational product and conducting study activities prior to obtaining informed consent from human subjects. These findings indicate serious non-compliance with regulations governing clinical trials and human subject protection.

## Related Documents

- [WARNING_LETTER - 2021-09-21](https://www.keypedia.com/records/warning_letter/sabine-s-hazan-md/ffb95b24-1101-4627-bf0d-d406189542ec)

## Related Officers

- [Linda Galindo](https://www.keypedia.com/people/linda-galindo/6bc29df6-192b-4d89-92ae-20cc1660d9ad)
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Company: https://www.keypedia.com/companies/sabine-s-hazan-md/f3e0166f-5a12-44dc-97ea-7fc311692525

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6