Warning letter
Roche Diagnostics Corporation: warning letter of Jun 11, 2003
FDA warning letter UCM147916 · Center for Devices and Radiological Health
Key facts
| Reference number | UCM147916 |
|---|---|
| Company | Roche Diagnostics Corporation |
| Subject | Quality System Regulation/Adulterated |
| Issue date | Jun 11, 2003 |
| Posted date | Jun 11, 2003 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 820, 820.40 |
| Country | 3 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
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: