FDA Inspection 629513 — Alkem Laboratories Ltd., Bioequivalence Centre
The FDA completed an inspection of Alkem Laboratories Ltd., Bioequivalence Centre on October 1, 2009 in Navi Mumbai. 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
- October 1, 2009
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Navi Mumbai (India)