Novartis Pharmaceuticals A. G. - March 23, 2017
Issue Date
Mar 23, 2017
Region
Southwest
Category
Drug
$117.00
Contact Name
Laura M. Pethick
Contact Title
Director Phar macovigilance and Risk Management
Address 1
11101 W. 120th Ave.
Address 2
Ste. 120
City
Broomfield
State
CO
Zip/Postal Code
80021 - 3436
Country
United States
Inspection Range
Mar 20, 2017 - Mar 23, 2017
Pages
3
First Observation
You, as a non-applicant electing not to submit to the applicant all reports of serious and unexpected
adverse drug experiences, failed to submit all repo1ts directly to FDA within 15 calendar days of your receipt of the adverse drug experience information.
Investigator(s): Jamie L. Dion and Tenzin Jangchup