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483
•Karim Chamie, M.D.•December 14, 2022

Karim Chamie, M.D. – FDA 483, Dec 14, 2022

Record Details

Karim NMI Chamie, MD, a Clinical Investigator in Los Angeles, CA, was cited for failing to conduct an investigation in accordance with the investigational plan. The inspection revealed significant deviations, including the enrollment of ineligible subjects and the failure to perform required biopsies and collect cytology samples for multiple subjects. These issues indicate a serious lack of adherence to study protocol and data collection requirements.

Company
Karim Chamie, M.D.
Inspection date
December 14, 2022
Product type
drugs
Office
Division of Pharmaceutical Quality Operations IV
Person
  • Christina D. Mello
View Company Profile

ID · 16a60cbf-c866-4d03-b101-9d491aeb6a08

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