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948389

Thoratec LLC — FEI 2916596

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
November 23, 2015
Fiscal Year
2016
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Pleasanton, CA (United States)

Facility

Other inspections at this facility

  • 1132047 (NAI Fri Oct 09 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1020165 (NAI Mon Jun 12 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 866589 (NAI Fri Feb 28 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 839933 (NAI Mon Jul 15 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 786667 (NAI Fri May 18 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
319221 CFR 820.30(g)Design validation - user needs and intended uses
326221 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate