631013
Encision Inc. — FEI 1000117361
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 2, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Boulder, CO (United States)
Citations
| ID | CFR | Description |
|---|
| 2431 | 21 CFR 820.30(b) | Design plans- updated |
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3371 | 21 CFR 820.198(a)(3) | Processing MDRs {see also 803, 804} |
| 3689 | 21 CFR 820.100(a)(2) | Investigation |
| 3692 | 21 CFR 820.100(a)(4) | CAPA verification/validation of corrective/preventive action |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |
| 735 | 21 CFR 803.50(b)(3) | Conducting an Investigation |