Warning letter
Selder S.A. de C.V.: warning letter of Apr 27, 2012
FDA warning letter UCM303962 · Center for Drug Evaluation and Research
Key facts
| Reference number | UCM303962 |
|---|---|
| Company | Selder S.A. de C.V. |
| Subject | CGMP/Finished Pharmaceuticals/Misbranded |
| Issue date | Apr 27, 2012 |
| Posted date | Apr 27, 2012 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 211.165(e), 341.72(c)(6)(ii), 201.326(a)(1)(iv), 211.100(a), 211.110(a), 211.166(a), 211.194(a), 201.326(a)(1)(iii), 341.72(c) |
| Country | 3 |
| Inspection city | Ciudad De Mexico |
| Inspection start date | Sep 20, 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: