# FDA 483 - Protagonist Therapeutics Inc - April 03, 2026

Source: https://www.keypedia.com/records/483/protagonist-therapeutics-inc/7f53277c-e3b6-41fb-bb68-3d88529a875e

> FDA 483 for Protagonist Therapeutics Inc on April 03, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Protagonist Therapeutics Inc
- Inspection Date: 2026-04-03
- Product Type: drugs
- Office Name: San Francisco District Office
- Summary: 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.

## Related Officers

- [Kristin M. Abaonza](https://www.keypedia.com/people/kristin-m-abaonza/cf909da8-837d-4dfe-9ccc-288b24d7bba3)

Company: https://www.keypedia.com/companies/protagonist-therapeutics-inc/5c51bacb-7fdd-4bbd-aa5b-5cf279320f4d

Office: https://www.keypedia.com/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df