870074
IBT Scientific Llc — FEI 1000139989
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 18, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Elkhart, IN (United States)
Citations
| ID | CFR | Description |
|---|
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3310 | 21 CFR 820.120(b) | DHR documentation of label release {see also 820.184} |