866244
Rowny Systems, Inc. — FEI 3009768528
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 10, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Cabin John, MD (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3149 | 21 CFR 820.180 | Availability |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |