Warning letter
LumiQuick Diagnostics Inc.: warning letter of Apr 1, 2014
FDA warning letter 423587 · San Francisco District Office
Key facts
| Reference number | 423587 |
|---|---|
| Company | LumiQuick Diagnostics Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Apr 1, 2014 |
| Posted date | Apr 1, 2014 |
| Issuing office | San Francisco District Office |
| Product type | Devices |
| CFR sections cited | 820, 820.40 |
| Inspection city | Santa Clara |
| Inspection ZIP | 95054 |
| Inspection start date | Feb 4, 2014 |
| 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: