Warning letter
Stryker Instruments Div. of Stryker Corporation: warning letter of Mar 6, 2013
FDA warning letter 388982 · Detroit District Office
Key facts
| Reference number | 388982 |
|---|---|
| Company | Stryker Instruments Div. of Stryker Corporation |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Mar 6, 2013 |
| Posted date | Mar 6, 2013 |
| Issuing office | Detroit District Office |
| Product type | Devices |
| CFR sections cited | 806.10, 806.2(j), 820, 807.81(b) |
| Inspection city | Portage |
| Inspection ZIP | 49002 |
| Inspection start date | Oct 29, 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: