Laboratorios Baxter SA - June 8, 2018
Issue Date
Jun 08, 2018
Region
HQ
Category
Drug
$117.00
Contact Name
Andres Ruiz Hurtado
Contact Title
Manufacturing Manager
Address 1
Calle 36 2C 22
Address 2
Barrio Santander
City
Cali, Valle Del Cauca
Zip/Postal Code
760003
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 and Cheryl Clausen