899273
9mm Special Effects — FEI 3009537647
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 30, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Haiku, HI (United States)
Citations
| ID | CFR | Description |
|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3139 | 21 CFR 820.140 | Lack of or inadequate procedures for handling |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |