483
Kasia Osadzinska, MDFDA 483 - Kasia Osadzinska, MD - June 15, 2021
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Record Details
The FDA inspected Cornerstone Research Institute (Kasia Osadzinska, MD) in Altamonte Springs, FL, regarding a Phase 3 clinical trial (Protocol HTX-011-302). The inspection revealed that the investigation was not conducted in accordance with the investigational plan. Specifically, subjects received rescue medication doses exceeding protocol limits and ineligible subjects were enrolled into the study.
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ID · 29536a33-4ad1-45b3-b416-14ed032ad304