894276
Omega Medical Imaging, Inc. — FEI 1000222289
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 5, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Sanford, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 4212 | 21 CFR 806.20(b)(4) | Justification for not reporting |
| 5007 | 21 CFR 1002.13 | Failure to submit |