556128
Omega Medical Imaging, Inc. — FEI 1000222289
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- January 9, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: 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 |