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1199287

Conformis, Inc. — FEI 3009844603

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 9, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Compliance: Devices
Location
Billerica, MA (United States)

Facility

Other inspections at this facility

  • 1102363 (VAI Fri Sep 20 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1064815 (VAI Fri Sep 07 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 929855 (NAI Fri Jun 12 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 823060 (NAI Mon Mar 18 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
1471421 CFR 820.30(c)Design input - Lack of or inadequate procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
317221 CFR 820.198(c)Investigation of device failures