Warning letter
Fresenius Kabi AG: warning letter of Sep 22, 2026
FDA warning letter 733107 · Center for Drug Evaluation and Research (CDER)
Key facts
| Reference number | 733107 |
|---|---|
| Company | Fresenius Kabi AG |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Sep 22, 2026 |
| Posted date | Sep 29, 2026 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Product type | Food/Cosmetics |
| CFR sections cited | 211.34, 211.42(c)(10), 211.110(a), 211.113(b), 211.192 |
| Inspection city | Melrose Park |
| Inspection ZIP | 60160 |
| Inspection start date | Jan 27, 2026 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- 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: