Warning letter
MEDDEV USA, INC.: warning letter of Oct 9, 2012
FDA warning letter 354319 · Dallas District Office
Key facts
| Reference number | 354319 |
|---|---|
| Company | MEDDEV USA, INC. |
| Subject | Medical Devices/Adulterated/Quality System Regulation (QSR) |
| Issue date | Oct 9, 2012 |
| Posted date | Oct 9, 2012 |
| Issuing office | Dallas District Office |
| Product type | Devices |
| CFR sections cited | 803.17, 820, 820.40, 807.81(b), 803 |
| Inspection city | Dallas |
| Inspection ZIP | 75205 |
| Inspection start date | May 9, 2012 |
| 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: