Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3008814558.
Observations2
Issue DateDecember 12, 2014
StatusNo Warning Letter
Related Inspections2
Establishment Details
Firm
Cardiovascular Systems, Inc.
Location
Pearland, Texas, United States
FEI Number
3008814558
Product Type
Devices
Issue Date
December 12, 2014
Country
United States
Inspection History, 2014 to 2016
NAI1
VAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated.