FDA Inspection 556128 — Omega Medical Imaging, Inc.
The FDA completed an inspection of Omega Medical Imaging, Inc. on Jan 9, 2009 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 9, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Sanford, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3157 | 21 CFR 820.181(c) | DMR QA procedures and specifications |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |