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1211189

SpineSmith Holdings, LLC — FEI 3006404071

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 1, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Austin, TX (United States)

Facility

Other inspections at this facility

  • 1040452 (VAI Fri Feb 09 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1035321 (NAI Wed Nov 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 889401 (NAI Wed Jul 23 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 816815 (VAI Thu Jan 31 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 788200 (NAI Mon Jun 25 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
311721 CFR 820.70(i)Software validation for automated processes
313021 CFR 820.100(a)Lack of or inadequate procedures
316021 CFR 820.184Lack of or inadequate DHR procedures
317321 CFR 820.198(d)Evaluation, timeliness, identification
341521 CFR 820.22Quality Audit/Reaudit - conducted
367721 CFR 820.30(g)Design validation - software validation not performed
383721 CFR 820.25(b)Training records