FDA Inspection 917945 — Globus Medical, Inc.
The FDA completed an inspection of Globus Medical, Inc. on Mar 23, 2015 in West Norriton, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 23, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: 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 |