FDA Inspection 836411 — Globus Medical, Inc.
The FDA completed an inspection of Globus Medical, Inc. on June 4, 2013 in West Norriton, PA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 4, 2013
- Fiscal Year
- 2013
- 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 |
| 3434 | 21 CFR 820.75(c) | Documentation - review in response to changes or deviations |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |