483
Ardelyx, Inc.FDA 483 - Ardelyx, Inc. - July 24, 2023
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Record Details
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.
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ID · f6bc713b-a39b-4c43-8612-18defe062b7e