FDA Inspection
Globus Medical, Inc.Globus Medical, Inc. – FDA Inspection, Jun 4, 2013
Record Details
This FDA Inspection record concerns Globus Medical, Inc., with an inspection on June 4, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Globus Medical, Inc.
- Inspection Date
- June 4, 2013
- Product Type
- Devices
View Company Profile
ID · d8031496-8c16-4f51-9bf4-4225ed4db451
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 836411
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.75(c)Documentation - review in response to changes or deviations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Globus Medical, Inc.
20| Date | Classification | Office | Project area |
|---|---|---|---|
| August 21, 2026 | Not classified | Philadelphia District Office | |
| August 13, 2026 | Not classified | Philadelphia District Office | |
| October 16, 2025 | VAI | Philadelphia District Office | Compliance: Medical Devices |
| March 7, 2024 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 12, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Globus Medical, Inc.
- FDA Inspection 1327570 - 2026-08-21
- FDA Inspection 1291174 - 2026-08-13
- FDA Inspection 1253116 - 2025-10-16
- FDA Inspection 1230609 - 2024-03-07
- FDA Inspection 1170933 - 2022-05-12
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