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FDA Inspection 1281830 — Spinal Elements, Inc

Spinal Elements, Inc — FEI 3004893332

The FDA completed an inspection of Spinal Elements, Inc on September 8, 2025 in Carlsbad, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). Product area: Biologics.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
September 8, 2025
Fiscal Year
2025
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Carlsbad, CA (United States)

Facility

Other inspections at this facility

  • 1095313 (NAI Tue May 14 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1028593 (NAI Fri Sep 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 863246 (OAI Wed Jan 15 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 846624 (VAI Fri Aug 30 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

FDA data resources