Warning letter
Smith & Nephew, Inc.: warning letter of Jun 11, 2014
FDA warning letter 418706 · Florida District Office
Key facts
| Reference number | 418706 |
|---|---|
| Company | Smith & Nephew, Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Jun 11, 2014 |
| Posted date | Jul 8, 2014 |
| Issuing office | Florida District Office |
| Product type | Devices |
| CFR sections cited | 806.10, 807.81(a)(3)(i), 820, 807.81(b), 7, 806 |
| Inspection city | Saint Petersburg |
| Inspection ZIP | 33716 |
| Inspection start date | Nov 12, 2013 |
| 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: