1019048
Straumann USA LLC — FEI 1000121052
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 21, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Andover, MA (United States)
Citations
| ID | CFR | Description |
|---|
| 12411 | 21 CFR 1271.260(a) | Contamination, mix ups, improper release |
| 12425 | 21 CFR 1271.265(c)(1) | Release of HCT/Ps by responsible person |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 4193 | 21 CFR 806.10(b) | Time to report - 10 days |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |