FDA Inspection 777613 — Spacelabs Healthcare, Inc.
The FDA completed an inspection of Spacelabs Healthcare, Inc. on April 18, 2012 in Snoqualmie, WA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- April 18, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Snoqualmie, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |