Warning letter
Spacelabs Healthcare Incorporated: warning letter of Nov 3, 2008
FDA warning letter 12286 · Seattle District Office
Key facts
| Reference number | 12286 |
|---|---|
| Company | Spacelabs Healthcare Incorporated |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Nov 3, 2008 |
| Posted date | Nov 3, 2008 |
| Issuing office | Seattle District Office |
| Product type | Devices |
| CFR sections cited | 803, 803.50, 803.50(a)(2), 820 |
| Inspection city | Snoqualmie |
| Inspection ZIP | 98065-9216 |
| Inspection start date | Apr 15, 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: