FDA inspection
Apotex Pharmachem India Pvt Ltd.: FDA inspection ending Jan 31, 2014
FDA inspection 868946 · Official Action Indicated (OAI) · Bangalore
Key facts
| Inspection ID | 868946 |
|---|---|
| Firm | Apotex Pharmachem India Pvt Ltd. |
| FEI number | 3005466325 |
| Address | Plot 1a Bommasandra Industrial Area 4th Phase, Jigani Link Road, Bommasandra Ind. Estate |
| City | Bangalore |
| Country | India |
| Fiscal year | 2014 |
| Inspection end date | Jan 31, 2014 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
| Warning letter | 423752 |
At a glance
- None Citations
- 1–9 Posted citations
- Yes 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