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1019539

Surgical Instrument Manufacturers, LLC — FEI 1935627

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
May 11, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Postmarket Assurance: 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))
  • 863893 (VAI Wed Jan 15 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 674762 (VAI Tue Jul 20 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
235021 CFR 820.25(b)Training - Lack of or inadequate procedures
320321 CFR 820.40(b)Document change records, maintained.
54621 CFR 820.75(a)Lack of or inadequate process validation