Warning letter
Wyeth Lederle S.p.A: warning letter of Mar 27, 2013
FDA warning letter 385159 · Center for Drug Evaluation and Research
Key facts
| Reference number | 385159 |
|---|---|
| Company | Wyeth Lederle S.p.A |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Mar 27, 2013 |
| Posted date | Mar 27, 2013 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 314.81(b)(1)(i), 211.192, 314.81(b)(1)(ii) |
| Inspection city | Catania |
| Inspection start date | Jul 9, 2012 |
| 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: