Warning letter
Fresenius Medical Care AG & Co. KGaA: warning letter of Aug 25, 2026
FDA warning letter 730319 · Center for Drug Evaluation and Research (CDER)
Key facts
| Reference number | 730319 |
|---|---|
| Company | Fresenius Medical Care AG & Co. KGaA |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Aug 25, 2026 |
| Posted date | Sep 1, 2026 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Product type | Drugs |
| CFR sections cited | 211.34, 211.100(a), 211.192 |
| Inspection city | Ogden |
| Inspection ZIP | 84404 |
| Inspection start date | Mar 2, 2026 |
| 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: