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705415

Alphatec Spine, Inc. — FEI 2027467

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 13, 2010
Fiscal Year
2011
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Carlsbad, CA (United States)

Facility

Other inspections at this facility

  • 1175442 (NAI Mon Jul 18 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1020129 (NAI Wed Apr 19 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 917997 (VAI Fri Mar 13 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 836180 (NAI Fri Jun 14 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 779000 (VAI Fri Apr 27 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
323321 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
366921 CFR 820.20(c)Management review - defined interval, sufficient frequency
383721 CFR 820.25(b)Training records
53721 CFR 820.70(a)Production processes
54621 CFR 820.75(a)Lack of or inadequate process validation
81221 CFR 803.56Submission of Supplement to Individual Report Within One Month