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1019065

Zimmer Manufacturing B.V. — FEI 1000132037

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 20, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Compliance: Devices
Location
Mercedita, PR (United States)

Facility

Other inspections at this facility

  • 1133679 (NAI Thu Oct 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 950318 (VAI Tue Nov 17 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 884721 (OAI Wed Jun 11 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 845339 (OAI Fri Aug 16 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 822907 (OAI Fri May 17 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
311921 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
369621 CFR 820.100(b)Documentation
54621 CFR 820.75(a)Lack of or inadequate process validation