Warning letter
ID Biomedical Corp., a subsidary of GSK Biologicals: warning letter of Jun 12, 2014
FDA warning letter 430282 · Center for Biologics Evaluation and Research
Key facts
| Reference number | 430282 |
|---|---|
| Company | ID Biomedical Corp., a subsidary of GSK Biologicals |
| Subject | CGMP/Deviations/Biologics License Application(BLA) |
| Issue date | Jun 12, 2014 |
| Posted date | Jun 24, 2014 |
| Issuing office | Center for Biologics Evaluation and Research |
| Product type | Biologics |
| CFR sections cited | 211.113(b) |
| Inspection city | Quebec |
| Inspection start date | Mar 31, 2014 |
| 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: