809912
DePuy Orthopaedics, Inc. — FEI 1818910
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 26, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Warsaw, IN (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |