866589

Thoratec LLC — FEI 2916596

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
February 28, 2014
Fiscal Year
2014
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Pleasanton, CA (United States)

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
326221 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures