992413
Pedicraft, Inc. — FEI 1043568
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- October 19, 2016
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Jacksonville, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 14718 | 21 CFR 820.30(g) | Design validation - Risk analysis |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |