Warning letter
Derma Pen, LLC: warning letter of Jan 9, 2015
FDA warning letter 437705 · Denver District Office
Key facts
| Reference number | 437705 |
|---|---|
| Company | Derma Pen, LLC |
| Subject | Premarket Approval/Misbranded/Adulterated |
| Issue date | Jan 9, 2015 |
| Posted date | Jan 20, 2015 |
| Issuing office | Denver District Office |
| Product type | Devices |
| CFR sections cited | 878.4820, 807.81(b), 878.9(b) |
| Inspection city | Salt Lake City |
| Inspection ZIP | 84106 |
| Inspection start date | Jul 16, 2014 |
| 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: