FDA Inspection 1112791 — Amgen, Inc.

Amgen, Inc. — FEI 2026154

The FDA completed an inspection of Amgen, Inc. on December 13, 2019 in Thousand Oaks, CA. 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
December 13, 2019
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Thousand Oaks, CA (United States)

Citations

IDCFRDescription
122421 CFR 211.67(b)(6)Cleaning SOP/inspection