Warning letter
iVu Imaging Corporation [ARCHIVED]: warning letter of Aug 31, 2010
FDA warning letter 144092 · Dallas District Office
Key facts
| Reference number | 144092 |
|---|---|
| Company | iVu Imaging Corporation [ARCHIVED] |
| Subject | CGMP/QSR/Adulterated/Manufacture/Packing/Storage/Installation |
| Issue date | Aug 31, 2010 |
| Posted date | Aug 31, 2010 |
| Issuing office | Dallas District Office |
| Product type | Devices |
| CFR sections cited | 820, 820.40 |
| Inspection city | Southlake |
| Inspection ZIP | 76092 |
| Inspection start date | Feb 24, 2010 |
| 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: