FDA Inspection 1010399 — Resuscitation International LLC
The FDA completed an inspection of Resuscitation International LLC on April 11, 2017 in Scottsdale, AZ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 11, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Scottsdale, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2431 | 21 CFR 820.30(b) | Design plans- updated |
| 2630 | 21 CFR 820.30(e) | Design review - documentation |
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |