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Biocon Ltd. - June 3, 2017

Issue Date

Jun 03, 2017

Region

HQ

Category

Drug
$117.00

Biocon Ltd.

Contact Name

Arun Chandavakar

Contact Title

CEO and Managing Director

Form483 Address 1

Plot 2-4, Phase IV, Bommasandra-Jigani Link Rd.

Form483 Address 2

Bommasandra

Form483 City

Post Bangalore, Kamataka

Form483 State

Form483 Postal

560099

Form483 Country

India

Inspection Range

May 25, 2017 - Jun 03, 2017

Pages

7

First Observation

Investigations of an unexplained discrepancy did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.
Investigator(s): Sandra A. Hughes, Eileen A. Lui