Novartis Pharmaceuticals Corp. - Aug. 21, 2019
Issue Date
Aug 21, 2019
Region
Central
Category
Drug
$117.00
Contact Name
Stan T. Howell
Contact Title
Site Head
Address 1
220 E. Hanover Ave.
City
Morris Plains
State
NJ
Zip/Postal Code
07950- 2445
Country
United States
Inspection Range
Aug 13, 2019 - Aug 21, 2019
Pages
7
First Observation
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Investigator(s): Jacqueline M. Diaz Albert, Susan M. Jackson, and Kimberly Schultz