Warning letter
Greiner Bio One Brasil Produtos Medicos Hospitalares Ltda.: warning letter of Aug 8, 2014
FDA warning letter 423198 · Center for Devices and Radiological Health
Key facts
| Reference number | 423198 |
|---|---|
| Company | Greiner Bio One Brasil Produtos Medicos Hospitalares Ltda. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Aug 8, 2014 |
| Posted date | Dec 1, 2014 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 806, 803, 820 |
| Inspection city | Americana |
| Inspection start date | Jan 13, 2014 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- NAI 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: