Warning letter
Apotex Inc. [ARCHIVED]: warning letter of Jun 25, 2009
FDA warning letter 58142 · Center for Drug Evaluation and Research
Key facts
| Reference number | 58142 |
|---|---|
| Company | Apotex Inc. [ARCHIVED] |
| Subject | CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated |
| Issue date | Jun 25, 2009 |
| Posted date | Jun 25, 2009 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 314.81(b)(1)(i), 314.81(b)(1), 314.81, 211.192, 211.186(b)(8) |
| Inspection city | Etobicoke |
| Inspection start date | Dec 10, 2008 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: