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786667

Thoratec LLC — FEI 2916596

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
May 18, 2012
Fiscal Year
2012
Product Type
Devices
Project Area
Compliance: 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))
  • 948389 (NAI Mon Nov 23 2015 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))

Recent compliance actions

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
1471421 CFR 820.30(c)Design input - Lack of or inadequate procedures
319221 CFR 820.30(g)Design validation - user needs and intended uses