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808236

LeMaitre Vascular, Inc. — FEI 1220948

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 31, 2012
Fiscal Year
2013
Product Type
Devices
Project Area
Compliance: Devices
Location
Burlington, MA (United States)

Facility

Other inspections at this facility

  • 1206543 (VAI Tue May 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1172108 (VAI Wed Jun 15 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1148251 (NAI Mon Jul 26 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1129204 (NAI Thu Aug 27 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1023176 (NAI Tue Aug 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
232821 CFR 820.22Quality audits - auditor independence
323221 CFR 820.72(a)Equipment suitability & capability
369621 CFR 820.100(b)Documentation
407021 CFR 820.30(g)Design validation - documentation
44721 CFR 820.40Lack of procedures, or not maintained