FDA Inspection 998189 — Alkem Laboratories Limited

Alkem Laboratories Limited — FEI 3006851796

The FDA completed an inspection of Alkem Laboratories Limited on December 9, 2016 in Ankleshwar. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 9, 2016
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Ankleshwar (India)