1149181
Denterprise International, Inc. — FEI 1000113729
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 19, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Ormond Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 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 |
| 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 |
| 5700 | 21 CFR 1002.10 | Failure to submit, distinct marking |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |