982613
Denterprise International, Inc. — FEI 1000113729
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 29, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Ormond Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2269 | 21 CFR 820.20(a) | Quality policy and objectives |
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 5031 | 21 CFR 1010.2(a) | Lack of certification of conformance |
| 5042 | 21 CFR 1010.3(a) | ID label or tag |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |