788078
Lucero Medical LLC — FEI 3008775608
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 8, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Richfield, OH (United States)
Citations
| ID | CFR | Description |
|---|
| 14715 | 21 CFR 820.30(d) | Design output - Lack of or inadequate procedures |
| 14718 | 21 CFR 820.30(g) | Design validation - Risk analysis |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3138 | 21 CFR 820.130 | Packaging |
| 3139 | 21 CFR 820.140 | Lack of or inadequate procedures for handling |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |