Warning letter
Optovue Inc. [ARCHIVED]: warning letter of Jun 11, 2010
FDA warning letter 104365 · San Francisco District Office
Key facts
| Reference number | 104365 |
|---|---|
| Company | Optovue Inc. [ARCHIVED] |
| Subject | CGMP/QSR/Medical Devices/Adulterated/Misbranded |
| Issue date | Jun 11, 2010 |
| Posted date | Jun 11, 2010 |
| Issuing office | San Francisco District Office |
| Product type | Devices |
| CFR sections cited | 803, 803.17, 820, 807.81(b) |
| Inspection city | Fremont |
| Inspection ZIP | 94538 |
| Inspection start date | Dec 8, 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: