# FDA 483 - Ardelyx, Inc. - July 24, 2023

Source: https://www.globalkeysolutions.net/records/483/ardelyx-inc/f6bc713b-a39b-4c43-8612-18defe062b7e

> FDA 483 for Ardelyx, Inc. on July 24, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ardelyx, Inc.
- Inspection Date: 2023-07-24
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Ardelyx, Inc. in Fremont, CA, underwent an inspection focused on Postmarketing Adverse Drug Experience (PADE) Reporting. The inspection identified one observation related to the firm's failure to develop written procedures. Specifically, the firm lacked procedures for the surveillance of postmarketing adverse drug experiences, including those from social media outlets.

## Related Documents

- [CRL - Unknown Date](https://www.globalkeysolutions.net/records/crl/ardelyx-inc/7dc0eefb-e0de-419d-829d-78b5a4e24878)

## Related Officers

- [Scott N. Lim](https://www.globalkeysolutions.net/people/scott-n-lim/d5e7745a-d804-48d1-8f3b-a94a8d4aed8a)

Company: https://www.globalkeysolutions.net/companies/ardelyx-inc/ca34caa9-3440-4e27-a0d0-177a42cc469e

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