Warning letter
Sanofi Pasteur: warning letter of Jul 12, 2012
FDA warning letter 309618 · Center for Biologics Evaluation and Research
Key facts
| Reference number | 309618 |
|---|---|
| Company | Sanofi Pasteur |
| Subject | CGMP Deviations |
| Issue date | Jul 12, 2012 |
| Posted date | Jul 12, 2012 |
| Issuing office | Center for Biologics Evaluation and Research |
| Product type | Biologics |
| CFR sections cited | 211.165(e), 211.192, 211.42(c)(10)(iv), 211.42(c)(10)(v), 211.113(b), 211.160(b), 211.166(a), 601.12 |
| Inspection city | Marcy-L'Etoile |
| Inspection start date | Mar 19, 2012 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- 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: