FDA 483 - Onyx Pharmaceuticals, Inc. - October 08, 2026

Onyx Pharmaceuticals, Inc. in Richmond, CA, was cited for significant deficiencies in its clinical trial oversight, specifically regarding the reporting and review of adverse events. The firm failed to report unexpected and serious adverse events within the required 15-day timeframe and inadequately reviewed safety reports. Additionally, the company did not conduct sufficient follow-ups to gather necessary information on serious adverse events, hindering proper reporting determinations.