Hadi Yaziji - Oct. 17, 2016
Issue Date
Oct 17, 2016
Region
Southeast
Category
Clinical
$117.00
Contact Name
Viviana Urena
Contact Title
Director of Client Services and Marketing
Address 1
8700 W. Flagler St.
City
Miami
State
FL
Zip/Postal Code
33174
Country
United States
Inspection Range
Oct 05, 2016 - Oct 17, 2016
Pages
2
First Observation
A clinical investigation requiring prior submission to the FDA was initiated without IRB review and IRB approval.
Investigator(s): Angelica M. Chica and Richard A. Lyght