Warning letter
Corden Pharma Latina S.p.A.: warning letter of May 20, 2016
FDA warning letter 484369 · Center for Drug Evaluation and Research
Key facts
| Reference number | 484369 |
|---|---|
| Company | Corden Pharma Latina S.p.A. |
| Subject | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Issue date | May 20, 2016 |
| Posted date | May 30, 2016 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 211.42(a), 211.67(a), 211.160(b) |
| Inspection city | Sermoneta |
| Inspection start date | May 21, 2015 |
| 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: