853148
Koko, LLC — FEI 1000117266
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- October 28, 2013
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Longmont, CO (United States)
Citations
| ID | CFR | Description |
|---|
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3147 | 21 CFR 820.170(a) | Lack of or inadequate instructions |
| 3239 | 21 CFR 820.72(b) | Remedial action - documentation |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 3837 | 21 CFR 820.25(b) | Training records |