FDA 483 - Protagonist Therapeutics Inc - April 03, 2026
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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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