Warning letter
Fresenius Medical Care AG & Co. KGaA: warning letter of Dec 4, 2023
FDA warning letter 666791 · Center for Devices and Radiological Health
Key facts
| Reference number | 666791 |
|---|---|
| Company | Fresenius Medical Care AG & Co. KGaA |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Dec 4, 2023 |
| Posted date | Dec 19, 2023 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 806, 820, 806.10(b) |
| Inspection city | Waltham |
| Inspection ZIP | 02451 |
| Inspection start date | Jun 26, 2023 |
| 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: