FDA inspection
Emcure Pharmaceuticals Limited: FDA inspection ending Feb 20, 2019
FDA inspection 1079858 · Official Action Indicated (OAI) · Pune
Key facts
| Inspection ID | 1079858 |
|---|---|
| Firm | Emcure Pharmaceuticals Limited |
| FEI number | 3005151215 |
| Address | Plot No. P-1 & P-2, It-Bt Park Phase Ii, Midc, Hinjwadi |
| City | Pune |
| Country | India |
| Fiscal year | 2019 |
| Inspection end date | Feb 20, 2019 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
| Warning letter | 576961 |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- Yes Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 10–99 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