Warning letter
Neurolumen LLC: warning letter of May 30, 2014
FDA warning letter 422220 · Dallas District Office
Key facts
| Reference number | 422220 |
|---|---|
| Company | Neurolumen LLC |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | May 30, 2014 |
| Posted date | Jun 10, 2014 |
| Issuing office | Dallas District Office |
| Product type | Devices |
| CFR sections cited | 807.81(b), 803, 803.17, 807.81(a)(3)(ii), 820, 820.40 |
| Inspection city | Oklahoma City |
| Inspection ZIP | 73120 |
| Inspection start date | Dec 10, 2013 |
| 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: