1117377
Inova Lasers LLC — FEI 3015191149
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 7, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- New York, NY (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 5032 | 21 CFR 1010.2(b) | Certification label or tag |
| 5034 | 21 CFR 1010.2(c) | Certification not based on adequate test/testing program |
| 5044 | 21 CFR 1010.3(a)(2) | ID label lacks place, month & year of manufacture |
| 5151 | 21 CFR 1040.10(f)(4) | Key control |
| 5171 | 21 CFR 1040.10(g)(3) | Class IV "Danger" label |
| 5208 | 21 CFR 1040.11(a)(2) | Calibration of measurement system |
| 5700 | 21 CFR 1002.10 | Failure to submit, distinct marking |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |