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821728

DS REP B.V. LLC — FEI 2647456

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 6, 2013
Fiscal Year
2013
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Las Piedras, PR (United States)

Facility

Other inspections at this facility

  • 1288064 (NAI Fri Oct 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1173360 (VAI Thu Jun 16 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1046784 (VAI Fri Mar 23 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 652360 (VAI Thu Mar 18 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
317221 CFR 820.198(c)Investigation of device failures
53921 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.