483
Nana Barseghian, M.D./Amicis Research CenterFDA 483 - Nana Barseghian, M.D./Amicis Research Center - February 16, 2024
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Record Details
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.
- Inspection Date
- February 16, 2024
- Product Type
- Drugs
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ID · 39804ed0-4d63-4e68-a575-dd7a8bee3e19