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863893

Surgical Instrument Manufacturers, LLC — FEI 1935627

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 15, 2014
Fiscal Year
2014
Product Type
Devices
Project Area
Compliance: Devices
Location
Fenton, MO (United States)

Facility

Other inspections at this facility

  • 1230704 (VAI Thu Feb 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1158788 (NAI Wed Oct 27 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1019539 (NAI Thu May 11 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 674762 (VAI Tue Jul 20 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
312821 CFR 820.90(a)Nonconforming product control
366921 CFR 820.20(c)Management review - defined interval, sufficient frequency
405921 CFR 820.22Quality Audits - defined intervals
54621 CFR 820.75(a)Lack of or inadequate process validation