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Novitium Pharma, Inc. - Feb. 4, 2019

Issue Date

Feb 04, 2019

Region

Central

Category

Drug
$117.00

Novitium Pharma, Inc.

Contact Name

George Schwab

Contact Title

Vice President of Quality Operations

Form483 Address 1

70 Lake Dr.

Form483 Address 2

Form483 City

East Windsor

Form483 State

NJ

Form483 Postal

08520

Form483 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