FDA Inspection
Globus Medical, Inc.Globus Medical, Inc. – FDA Inspection, Mar 23, 2015
Record Details
This FDA Inspection record concerns Globus Medical, Inc., with an inspection on March 23, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Globus Medical, Inc.
- Inspection Date
- March 23, 2015
- Product Type
- Devices
View Company Profile
ID · e3f3e7e7-9bbf-46df-a26b-3375c27e7e98
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 917945
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.72(a)Equipment suitability & capability
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
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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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