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Laboratorios Baxter SA - June 8, 2018

Issue Date

Jun 08, 2018

Region

HQ

Category

Drug
$117.00

Laboratorios Baxter SA

Contact Name

Andres Ruiz Hurtado

Contact Title

Manufacturing Manager

Form483 Address 1

Calle 36 2C 22

Form483 Address 2

Barrio Santander

Form483 City

Cali, Valle Del Cauca

Form483 State

Form483 Postal

760003

Form483 Country

Colombia

Inspection Range

Jun 04, 2018 - Jun 08, 2018

Pages

7

First Observation

Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of inprocess material and the drug product.
Investigator(s): Michael A. Charles, Cheryl Clausen