483
Protagonist Therapeutics IncProtagonist Therapeutics Inc – FDA 483, Apr 3, 2026
Record Details
An FDA inspection of Protagonist Therapeutics Inc in Newark, CA, from March 30 to April 3, 2026, revealed a significant failure in clinical study oversight. The firm did not provide investigators with necessary information for proper study conduct and failed to ensure adequate monitoring, resulting in undetected protocol deviations and delayed monitoring visits for multiple studies. This indicates a serious lapse in clinical trial management and patient safety protocols.
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