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FDA Inspection 548949 — Thoratec LLC

Thoratec LLC — FEI 2916596

The FDA completed an inspection of Thoratec LLC on November 12, 2008 in Pleasanton, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 12, 2008
Fiscal Year
2009
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Pleasanton, CA (United States)

Facility

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  • 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 (VAI Fri Feb 28 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

FDA data resources