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 3001451998.
Observations5
Issue DateSeptember 21, 2009
StatusNo Warning Letter
Related Inspections2
Establishment Details
Firm
Exempla Healthcare, IRB
Location
Denver, Colorado, United States
FEI Number
3001451998
Product Type
Drugs
Issue Date
September 21, 2009
Country
United States
Inspection History, 2009 to 2014
NAI1
VAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated.