Warning letter
Merck KGaA [ARCHIVED]: warning letter of Dec 15, 2011
FDA warning letter 214335 · Center for Drug Evaluation and Research
Key facts
| Reference number | 214335 |
|---|---|
| Company | Merck KGaA [ARCHIVED] |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Dec 15, 2011 |
| Posted date | Dec 15, 2011 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 211.113, 211.192, 211.198, 211.160(b), 601.12, 600.14(c) |
| Inspection city | Aubonne |
| Inspection start date | Jun 10, 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: