Warning letter
Fresenius Medical Care: warning letter of Jul 25, 2002
FDA warning letter UCM145031 · New Jersey District Office
Key facts
| Reference number | UCM145031 |
|---|---|
| Company | Fresenius Medical Care |
| Subject | Quality System Regulation for Medical Devices/Adulterated |
| Issue date | Jul 25, 2002 |
| Posted date | Jul 25, 2002 |
| Issuing office | New Jersey District Office |
| Product type | Devices |
| CFR sections cited | 820 |
| Country | 3 |
| Inspection city | Delran |
| Inspection ZIP | 08075-1233 |
| Inspection start date | Apr 2, 2002 |
| 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: