FDA Inspection
Globus Medical, Inc.Globus Medical, Inc. – FDA Inspection, Sep 30, 2010
Record Details
This FDA Inspection record concerns Globus Medical, Inc., with an inspection on September 30, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Globus Medical, Inc.
- Inspection Date
- September 30, 2010
- Product Type
- Devices
View Company Profile
ID · caca7dd0-6667-4e37-bad1-c2c54c058d4b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 685687
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(e)Records of complaint investigation
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 |
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- FDA Inspection 1253116 - 2025-10-16
- FDA Inspection 1230609 - 2024-03-07
- FDA Inspection 1170933 - 2022-05-12
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