938778
DoubleDay Acquisitions dba CSAFE Global — FEI 3009134624
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 4, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Monroe, OH (United States)
Citations
| ID | CFR | Description |
|---|
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 2630 | 21 CFR 820.30(e) | Design review - documentation |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3674 | 21 CFR 820.30(d) | Design output - documentation |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |