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1102954

Globus Medical, Inc. — FEI 3004142400

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 27, 2019
Fiscal Year
2019
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
West Norriton, PA (United States)

Facility

Other inspections at this facility

  • 1253116 (VAI Thu Oct 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1230609 (OAI Thu Mar 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1170933 (NAI Thu May 12 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1114734 (NAI Wed Oct 23 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1022878 (NAI Fri Aug 25 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1241621 CFR 1271.260(e)Storage temperatures recorded, maintained
1243221 CFR 1271.265(e)Documentation elements for activities
1243721 CFR 1271.270(a)Records incomplete
1472221 CFR 820.40Procedures not adequately established or maintained
313021 CFR 820.100(a)Lack of or inadequate procedures
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
367121 CFR 820.25(a)Personnel