916226
Neurotris, Inc. dba A1 Engineering — FEI 3008069988
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 18, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Irvine, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 2269 | 21 CFR 820.20(a) | Quality policy and objectives |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3175 | 21 CFR 820.186 | QSR |
| 3206 | 21 CFR 820.50(b) | Approval, inadequate purchasing data |
| 3226 | 21 CFR 820.70(g)(1) | Maintenance schedule, Lack of or inadequate schedule |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |