Warning letter
Elite Massagers, LLC.: warning letter of Dec 11, 2015
FDA warning letter 470283 · Dallas District Office
Key facts
| Reference number | 470283 |
|---|---|
| Company | Elite Massagers, LLC. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Dec 11, 2015 |
| Posted date | Dec 22, 2015 |
| Issuing office | Dallas District Office |
| Product type | Devices |
| CFR sections cited | 803.17, 803, 803.3, 803.11, 803.12, 803.10(c)(1), 803.10(c)(2), 803.10(c)(3), 803.17(a)(1), 803.17(a)(2), 803.17(a)(3), 807.81(a)(3)(ii) and 5 more |
| Inspection city | Allen |
| Inspection ZIP | 75002 |
| Inspection start date | Mar 25, 2015 |
| 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: