FDA Inspection 1140381 — Alkem Laboratories Limited
The FDA completed an inspection of Alkem Laboratories Limited on November 26, 2019 in Tehsil Nalagarh, Baddi. 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
- November 26, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tehsil Nalagarh, Baddi (India)
Additional Details
Mutual Recognition Agreement (MRA)