1210671

Ardelyx, Inc. — FEI 3010169178

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 24, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Fremont, CA (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Citations

IDCFRDescription
673021 CFR 314.80(b)Failure to develop written procedures