Novitium Pharma, Inc. - Feb. 4, 2019
Issue Date
Feb 04, 2019
Region
Central
Category
Drug
$117.00
Contact Name
George Schwab
Contact Title
Vice President of Quality Operations
Address 1
70 Lake Dr.
City
East Windsor
State
NJ
Zip/Postal Code
08520
Country
United States
Inspection Range
Jan 23, 2019 - Feb 04, 2019
Pages
2
First Observation
Changes to approved applications are not adequately assessed and controlled by the quality unit determining their impact on drug product quality.
Investigator(s): Frederick Razzaghi