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1153886

Materialise USA LLC — FEI 3005718816

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 6, 2021
Fiscal Year
2022
Product Type
Devices
Project Area
Compliance: Devices
Location
Plymouth, MI (United States)

Facility

Other inspections at this facility

  • 1022539 (NAI Tue Aug 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 925869 (VAI Tue May 12 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 858345 (VAI Tue Dec 10 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 720872 (VAI Fri Apr 22 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471421 CFR 820.30(c)Design input - Lack of or inadequate procedures
243021 CFR 820.30(b)Design plans - Lack of or inadequate
265021 CFR 820.30(f)Design verification - Lack of or inadequate procedures
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate