1230609
Globus Medical, Inc. — FEI 3004142400
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 7, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- West Norriton, PA (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 21432 | 21 CFR 803.18(b)(1)(iii) | Files do not include FDA's Acknowledgement of electronic MDR submissions |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |