869587
Environmental Tectonics Corp — FEI 2518447
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 25, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Southampton, PA (United States)
Citations
| ID | CFR | Description |
|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |
| 4212 | 21 CFR 806.20(b)(4) | Justification for not reporting |