Warning letter
Octapharma AB [ARCHIVED]: warning letter of Apr 15, 2011
FDA warning letter 179372 · Center for Biologics Evaluation and Research
Key facts
| Reference number | 179372 |
|---|---|
| Company | Octapharma AB [ARCHIVED] |
| Subject | CGMP Deviations |
| Issue date | Apr 15, 2011 |
| Posted date | Apr 15, 2011 |
| Issuing office | Center for Biologics Evaluation and Research |
| Product type | Biologics |
| CFR sections cited | 211.100, 211.192, 211.198, 211.160(b), 211.165(f), 600.14, 601.12, 640.101(c) |
| Inspection city | Stockholm |
| Inspection start date | Jan 10, 2011 |
| 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: