651866
Electro-Diagnostic Imaging, Inc. — FEI 3002900377
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 22, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Milpitas, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |
| 3328 | 21 CFR 820.180(b) | Retention period |
| 3369 | 21 CFR 820.198(a)(1) | Uniform and timely processing |
| 3371 | 21 CFR 820.198(a)(3) | Processing MDRs {see also 803, 804} |
| 3690 | 21 CFR 820.100(a)(3) | Identification of actions needed |
| 4212 | 21 CFR 806.20(b)(4) | Justification for not reporting |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |