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FDA Inspection
•Globus Medical, Inc.•August 25, 2017

Globus Medical, Inc. – FDA Inspection, Aug 25, 2017

Record Details

This FDA Inspection record concerns Globus Medical, Inc., with an inspection on August 25, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Globus Medical, Inc.
Inspection Date
August 25, 2017
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
People
  • Brian S. Keefer (FDA Associated Person)
  • Daniel T. Lee (Company Rep)
  • Kish Bolden (Issuing Officer)
View Company Profile

ID · ad02b27f-d448-4058-a873-136ff12dbdec

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1022878
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies
Outcome
Form 483 issued

FDA Citations

2
  1. 21 CFR 820.100(b)Documentation
  2. 21 CFR 820.50(a)(2)Supplier oversight

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Globus Medical, Inc.

20
DateClassificationOfficeProject area
August 21, 2026Not classifiedPhiladelphia District Office
August 13, 2026Not classifiedPhiladelphia District Office
October 16, 2025VAIPhiladelphia District OfficeCompliance: Medical Devices
March 7, 2024OAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
May 12, 2022NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
View all 20 other inspections on the company page
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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