FDA inspection
Alkem Laboratories Limited: FDA inspection ending Sep 29, 2016
FDA inspection 989408 · Voluntary Action Indicated (VAI) · Daman
Key facts
| Inspection ID | 989408 |
|---|---|
| Firm | Alkem Laboratories Limited |
| FEI number | 3006370524 |
| Address | 167 Mahatma Gandhi Udyog Nagar Road |
| City | Daman |
| Country | India |
| Fiscal year | 2016 |
| Inspection end date | Sep 29, 2016 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
At a glance
- 10–99 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data