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Sandoz Inc. - April 16, 2019

Issue Date

Apr 16, 2019

Region

Southwest

Category

Drug
$117.00

Sandoz Inc.

Contact Name

Antony S. Fraij

Contact Title

VP Technical Operations

Form483 Address 1

2555 W. Midway Blvd.

Form483 Address 2

Form483 City

Broomfield

Form483 State

CO

Form483 Postal

80020-1632

Form483 Country

United States

Inspection Range

Apr 08, 2019 - Apr 16, 2019

Pages

4

First Observation

There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Investigator(s): Erika V. Butler