FDA Inspection 1095886 — Athenex, Inc.

Athenex, Inc. — FEI 3012022182

The FDA completed an inspection of Athenex, Inc. on July 11, 2019 in Buffalo, NY. 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
July 11, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Buffalo, NY (United States)

Citations

IDCFRDescription
360221 CFR 211.160(a)Deviations from laboratory control requirements