FDA Inspection 1099175 — Esperion

Esperion — FEI 3012969684

The FDA completed an inspection of Esperion on August 9, 2019 in Ann Arbor, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 9, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Ann Arbor, MI (United States)

Additional Details

Sponsor, Contract Research Organization

Citations

IDCFRDescription
748221 CFR 312.50General responsibilities of sponsors