1044777
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 16, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Lakewood, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3286 | 21 CFR 820.90(b)(1) | Procedures for product review,disposition lack of/inadequate |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |