FDA Inspection 1022878 — Globus Medical, Inc.
The FDA completed an inspection of Globus Medical, Inc. on Aug 25, 2017 in West Norriton, PA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Aug 25, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- West Norriton, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 3696 | 21 CFR 820.100(b) | Documentation |