FDA Inspection 894276 — Omega Medical Imaging, Inc.
The FDA completed an inspection of Omega Medical Imaging, Inc. on Sep 5, 2014 in Sanford, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 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 |