Warning letter
Spectranetics Corporation: warning letter of May 23, 2016
FDA warning letter 491979 · Denver District Office
Key facts
| Reference number | 491979 |
|---|---|
| Company | Spectranetics Corporation |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | May 23, 2016 |
| Posted date | Jun 7, 2016 |
| Issuing office | Denver District Office |
| Product type | Devices |
| CFR sections cited | 820, 1002.11, 1002.20, 1010, 1010.2(c), 1040.10(f)(1), 1003.11(b) |
| Inspection city | Colorado Springs |
| Inspection ZIP | 80921 |
| Inspection start date | Nov 30, 2015 |
| 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: