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951676

Zimmer, Inc. — FEI 1000220733

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
November 20, 2015
Fiscal Year
2016
Product Type
Devices
Project Area
Compliance: Devices
Location
Warsaw, IN (United States)

Facility

Other inspections at this facility

  • 1177397 (NAI Wed Jul 27 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1029453 (VAI Mon Oct 16 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 880647 (OAI Wed May 28 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 865719 (VAI Fri Feb 07 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 844677 (OAI Mon Aug 19 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
310121 CFR 820.30(g)Design validation- Lack of or inadequate procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
313821 CFR 820.130Packaging
323721 CFR 820.72(b)Remedial action
326321 CFR 820.250(b)Sampling plans
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
367421 CFR 820.30(d)Design output - documentation
54621 CFR 820.75(a)Lack of or inadequate process validation
63221 CFR 803.17(a)(2)Lack of System for Determining MDR Events