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 1827503.
Observations2
Issue DateMay 10, 2013
StatusNo Warning Letter
Related Inspections2
Establishment Details
Firm
Lutheran Hospital IRB
Location
Fort Wayne, Indiana, United States
FEI Number
1827503
Product Type
Devices
Issue Date
May 10, 2013
Country
United States
Inspection History, 2010 to 2013
NAI1
VAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated.