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Home » Form 483 » Glenmark Pharmaceuticals, Ltd.

Glenmark Pharmaceuticals,Ltd. - April 20, 2019

Issue Date

Apr 20, 2019

Region

HQ

Category

Drug
$117.00

Contact Name

Derrick D. Slattery

Contact Title

Vice President and Cluster Head, Quality

Address 1

Village Kishanpura, Baddi Nalagarh Road, Baddi

City

Solan

State

Himachal Pradesh

Zip/Postal Code

173205

Country

India

Inspection Range

Apr 15, 2019 - Apr 20, 2019

Pages

11

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): Justin A. Boyd and Rita K. Kabaso
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