1090180
Denterprise International, Inc. — FEI 1000113729
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 6, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- 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 |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 5008 | 21 CFR 1002.20(a) | Failure to report |
| 5032 | 21 CFR 1010.2(b) | Certification label or tag |
| 5468 | 21 CFR 1020.30(j) | Mandatory warning on control panel |
| 5700 | 21 CFR 1002.10 | Failure to submit, distinct marking |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |