Warning letter
Stryker Craniomaxillofacial Division [ARCHIVED]: warning letter of May 5, 2009
FDA warning letter 50519 · Detroit District Office
Key facts
| Reference number | 50519 |
|---|---|
| Company | Stryker Craniomaxillofacial Division [ARCHIVED] |
| Subject | Premarket Approval/Misbranded/Adulterated |
| Issue date | May 5, 2009 |
| Posted date | May 5, 2009 |
| Issuing office | Detroit District Office |
| Product type | Devices |
| CFR sections cited | 806.10(c)(6), 807.81(a)(3), 807.81(a)(3)(i), 807.81(b), 806.10(c), 806 |
| Inspection city | Portage |
| Inspection ZIP | 49002 |
| Inspection start date | Dec 8, 2008 |
| 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: