FDA inspection
Alkem Laboratories Limited: FDA inspection ending Sep 18, 2015
FDA inspection 945929 · Voluntary Action Indicated (VAI) · Ankleshwar
Key facts
| Inspection ID | 945929 |
|---|---|
| Firm | Alkem Laboratories Limited |
| FEI number | 3008450172 |
| Address | No. 8, Old National Highway, At Naugama, Mandava, Bharuch district |
| City | Ankleshwar |
| Country | India |
| Fiscal year | 2015 |
| Inspection end date | Sep 18, 2015 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
At a glance
- None 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