942482
Spacelabs Healthcare, Inc. — FEI 3010157426
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 31, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Snoqualmie, WA (United States)
Citations
| ID | CFR | Description |
|---|
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 733 | 21 CFR 803.50(b)(1) | Reporting Information Reasonably Known |