917945
Globus Medical, Inc. — FEI 3004142400
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 23, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- West Norriton, PA (United States)
Citations
| ID | CFR | Description |
|---|
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3232 | 21 CFR 820.72(a) | Equipment suitability & capability |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |