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Sandoz Private Ltd. - April 12, 2019

Issue Date

Apr 12, 2019

Region

HQ

Category

Drug
$117.00

Sandoz Private Ltd.

Contact Name

Sundhir Bhandare

Contact Title

Head-Technical Operation- India and Site Head- Kalwe

Form483 Address 1

MIDC Plot No 8-A/2& 8-B, TTC Industrial Area, Kalwe Block- Village Digha

Form483 Address 2

Form483 City

Navi Mumbai

Form483 State

Maharashtra

Form483 Postal

400708

Form483 Country

India

Inspection Range

Apr 08, 2019 - Apr 12, 2019

Pages

2

First Observation

Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
Investigator(s): Yasamin Ameri