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911848

LeMaitre Vascular, Inc. — FEI 1000121696

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 28, 2015
Fiscal Year
2015
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
North Brunswick, NJ (United States)

Facility

Other inspections at this facility

  • 1235542 (NAI Wed Apr 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1202728 (VAI Thu Apr 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1044392 (NAI Fri Feb 16 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 816080 (NAI Fri Jan 25 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 704445 (NAI Mon Dec 20 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
315921 CFR 820.184DHR content
326321 CFR 820.250(b)Sampling plans
333121 CFR 820.181DMR - not or inadequately maintained
54621 CFR 820.75(a)Lack of or inadequate process validation