# FDA 483 - CymaBay Therapeutics, Inc. - March 20, 2024

Source: https://www.keypedia.com/records/483/cymabay-therapeutics-inc/03d76b87-cb4a-4fcd-8759-13a3f42333b0

> FDA 483 for CymaBay Therapeutics, Inc. on March 20, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CymaBay Therapeutics, Inc.
- Inspection Date: 2024-03-20
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: 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.

## Related Officers

- [Kristin M. Abaonza](https://www.keypedia.com/people/kristin-m-abaonza/cf909da8-837d-4dfe-9ccc-288b24d7bba3)
- [Cynthia J. Tsui](https://www.keypedia.com/people/cynthia-j-tsui/e02b5fd2-e90b-47a7-bbc2-e658f160c4ae)

Company: https://www.keypedia.com/companies/cymabay-therapeutics-inc/85c806d8-0957-4b82-8a01-6d47ea8d6f07

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b