Warning letter
Gambro Renal Products S.A. de C.V. [ARCHIVED]: warning letter of Jul 2, 2009
FDA warning letter 64043 · Center for Devices and Radiological Health
Key facts
| Reference number | 64043 |
|---|---|
| Company | Gambro Renal Products S.A. de C.V. [ARCHIVED] |
| Subject | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated |
| Issue date | Jul 2, 2009 |
| Posted date | Jul 2, 2009 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 820 |
| Inspection city | Tijuana |
| Inspection start date | Feb 16, 2009 |
| 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: