Berhane Seyoum - July 11, 2016
Issue Date
Jul 11, 2016
Region
Central
Category
Clinical
$117.00
Address 1
4201 St. Antoine
Address 2
UHC 4-H
City
Detroit
State
MI
Zip/Postal Code
48201
Country
United States
Inspection Range
Jun 23, 2016 - Jul 11, 2016
Pages
8
First Observation
Legally effective informed consent was not obtained from a subject or the subject's legally authorized representative, and the situation did not meet the criteria in 21 CFR 50.23-24 for exception.
Investigator(s): Andrace Deyampert and Neali H. Lucas