Warning letter
Isolux, LLC: warning letter of Jan 8, 2016
FDA warning letter 486738 · Florida District Office
Key facts
| Reference number | 486738 |
|---|---|
| Company | Isolux, LLC |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Jan 8, 2016 |
| Posted date | Jan 26, 2016 |
| Issuing office | Florida District Office |
| Product type | Devices |
| CFR sections cited | 820 |
| Inspection city | Chatsworth |
| Inspection ZIP | 91311 |
| Inspection start date | Nov 4, 2015 |
| 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: