CymaBay Therapeutics, Inc. – FDA 483, Mar 20, 2024

CYMABAY THERAPEUTICS, INC. in Fremont, CA, was inspected from March 12-20, 2024, and received one observation. The inspection revealed significant deficiencies in the firm's oversight of clinical studies, specifically regarding the provision of necessary information to investigators and ensuring proper study monitoring. These issues included inadequate training documentation, delayed distribution of updated Investigator's Brochures, inability to reconcile eCRF data with source documents, and untimely monitoring visits, which led to various protocol deviations and unrecorded adverse events.