Novartis Pharmaceuticals Corp. - Dec. 14, 2018
Issue Date
Dec 14, 2018
Region
Central
Category
Drug
$117.00
Contact Name
Paula Rinaldi
Contact Title
U.S. Head Regulatory Affairs
Address 1
1 Health Plz.
City
East Hanover
State
NJ
Zip/Postal Code
07936- 1016
Country
United States
Inspection Range
Dec 10, 2018 - Dec 14, 2018
Pages
3
First Observation
Failure to ensure proper monitoring of the study and ensure the study is conducted in accordance with the protocol and/or investigational plan.
Investigator(s): Kassa Ayalew, Cheryl A. Grandinetti, and Peter Lenahan