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 1832837.
Observations1
Issue DateDecember 16, 2013
StatusNo Warning Letter
Related Inspections4
Establishment Details
Firm
EKF Diagnostics, Inc. dba EFK Life Sciences
Location
Elkhart, Indiana, United States
FEI Number
1832837
Product Type
Devices
Issue Date
December 16, 2013
Country
United States
Inspection History, 2013 to 2022
NAI1
VAI3
NAI means No Action Indicated. VAI means Voluntary Action Indicated.