Warning letter
Fresenius Kabi Oncology Limited (Baddi): warning letter of Dec 17, 2017
FDA warning letter 526863 · Center for Drug Evaluation and Research
Key facts
| Reference number | 526863 |
|---|---|
| Company | Fresenius Kabi Oncology Limited (Baddi) |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Dec 17, 2017 |
| Posted date | Jan 2, 2018 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 211.34, 211.192 |
| Inspection city | Baddi |
| Inspection start date | Apr 6, 2017 |
| Letter on fda.gov | fda.gov |
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: