Warning letter
LumiQuick Diagnostics Inc.: warning letter of Jul 31, 2013
FDA warning letter 392748 · San Francisco District Office
Key facts
| Reference number | 392748 |
|---|---|
| Company | LumiQuick Diagnostics Inc. |
| Subject | Premarket Approval/Adulterated |
| Issue date | Jul 31, 2013 |
| Posted date | Jul 31, 2013 |
| Issuing office | San Francisco District Office |
| Product type | Devices |
| CFR sections cited | 803, 803.17, 806, 866.9, 866.3405, 803.17(a), 803.17(b), 820, 807.81(b), 866.9(c)(6) |
| Inspection city | Santa Clara |
| Inspection ZIP | 95054 |
| Inspection start date | Nov 26, 2012 |
| Letter on fda.gov | web.archive.org |
At a glance
- 10–99 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: