Warning letter
Neurotone Systems, Inc: warning letter of Apr 10, 2006
FDA warning letter UCM075863 · Dallas District Office
Key facts
| Reference number | UCM075863 |
|---|---|
| Company | Neurotone Systems, Inc |
| Subject | Current Good Manufacturing Practices Requirements for Medical Devices/Adulterated |
| Issue date | Apr 10, 2006 |
| Posted date | Apr 10, 2006 |
| Issuing office | Dallas District Office |
| Product type | Devices |
| CFR sections cited | 820, 803, 807.81, 820.40, 807.81(b) |
| Country | 3 |
| Inspection city | Garland |
| Inspection ZIP | 75041-3306 |
| Inspection start date | Sep 19, 2005 |
| 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: