FDA inspection
Apotex Inc.: FDA inspection ending Aug 14, 2009
FDA inspection 610738 · Official Action Indicated (OAI) · North York
Key facts
| Inspection ID | 610738 |
|---|---|
| Firm | Apotex Inc. |
| FEI number | 3002906944 |
| Address | 150 Signet Dr |
| City | North York |
| Country | Canada |
| Fiscal year | 2009 |
| Inspection end date | Aug 14, 2009 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
| Warning letter | 101627 |
At a glance
- None Citations
- 1–9 Posted citations
- Yes Warning letter followed
- Yes Form FDA 483 issued
- Yes 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