Jon B. Cole - April 26, 2019
Issue Date
Apr 26, 2019
Region
Central
Category
Clinical
$117.00
Address 1
Hennepin County Medical Center, Dept. Of Emergency Medicine
Address 2
701 Park Ave.
City
Minneapolis
State
MN
Zip/Postal Code
55415-1623
Country
United States
Inspection Range
Apr 10, 2019 - Apr 26, 2019
Pages
5
First Observation
The sponsor failed to submit an IND to the FDA prior to conducting a clinical investigation with an investigational new drug.
Investigator(s): Kellie L. Thommes