# FDA 483 - Nana Barseghian, M.D./Amicis Research Center - February 16, 2024

Source: https://www.globalkeysolutions.net/records/483/nana-barseghian-mdamicis-research-center/39804ed0-4d63-4e68-a575-dd7a8bee3e19

> FDA 483 for Nana Barseghian, M.D./Amicis Research Center on February 16, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nana Barseghian, M.D./Amicis Research Center
- Inspection Date: 2024-02-16
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Amicis Research Center in Northridge, CA, revealed significant deficiencies in the conduct of a clinical investigation for a COVID-19 drug. The firm failed to adhere to the investigational plan, maintain accurate case histories, and properly obtain informed consent from study participants. These issues indicate a lack of compliance with clinical trial protocols and regulatory requirements.

## Related Documents

- [WARNING_LETTER - 2024-02-16](https://www.globalkeysolutions.net/records/warning_letter/nana-barseghian-mdamicis-research-center/76ed0519-deaf-4b3d-bf44-bbc48f1b4aa3)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/cheron-m-portee/c2cf139d-e4ce-400d-893e-bd733b3ec3a9)
- [Jasmine Y. Wang](https://www.globalkeysolutions.net/people/jasmine-y-wang/e23c7335-477c-4671-8dcc-72e9149d424e)

Company: https://www.globalkeysolutions.net/companies/nana-barseghian-mdamicis-research-center/6eb0142f-c202-400c-a155-5034d5f06e62

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