Warning letter
Enhancement Medical, LLC: warning letter of Jun 4, 2014
FDA warning letter 420850 · Minneapolis District Office
Key facts
| Reference number | 420850 |
|---|---|
| Company | Enhancement Medical, LLC |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Jun 4, 2014 |
| Posted date | Jun 17, 2014 |
| Issuing office | Minneapolis District Office |
| Product type | Devices |
| CFR sections cited | 874.4780, 803, 803.3, 803.17, 806, 806.10, 803.20(c)(1), 820, 803.50(a), 874.9(a) |
| Inspection city | Milwaukee |
| Inspection ZIP | 53226 |
| Inspection start date | Dec 16, 2013 |
| 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: