Warning letter
Kronner Prototypes, Inc: warning letter of May 9, 2013
FDA warning letter 393572 · Seattle District Office
Key facts
| Reference number | 393572 |
|---|---|
| Company | Kronner Prototypes, Inc |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) |
| Issue date | May 9, 2013 |
| Posted date | May 9, 2013 |
| Issuing office | Seattle District Office |
| Product type | Devices |
| CFR sections cited | 820 |
| Inspection city | Roseburg |
| Inspection ZIP | 97471 |
| Inspection start date | Feb 1, 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: