FDA inspection
Apotex Research Private Limited: FDA inspection ending Nov 17, 2017
FDA inspection 1035038 · Official Action Indicated (OAI) · Bengaluru
Key facts
| Inspection ID | 1035038 |
|---|---|
| Firm | Apotex Research Private Limited |
| FEI number | 3006076314 |
| Address | Plots 1 And 2, Bommasandra Ind. Area, Jigani Link Rd; 4th Phase |
| City | Bengaluru |
| Country | India |
| Fiscal year | 2018 |
| Inspection end date | Nov 17, 2017 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
| Warning letter | 547439 |
At a glance
- None 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