1088391
OSKO, Inc. — FEI 3010666400
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 3, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Medley, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3147 | 21 CFR 820.170(a) | Lack of or inadequate instructions |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 5012 | 21 CFR 1003.10(a) | FDA not notified of defect or noncompliance |
| 537 | 21 CFR 820.70(a) | Production processes |
| 5472 | 21 CFR 1020.30(k) | Compliance measurements--diagnostic source assembly |
| 5479 | 21 CFR 1020.30(n) | Compliance measurement |
| 5700 | 21 CFR 1002.10 | Failure to submit, distinct marking |
| 5813 | 21 CFR 1002.30(a)(2) | Methods, devices, procedures for testing |