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Qualiphar Nv - May 7, 2010
Issue Date
May 07, 2010
Region
HQ
Category
Drug
$117.00
Address 1
Rijksweg 9
City
Bornem 2880
Country
BE
Inspection Range
May 03, 2010 - May 07, 2010
Pages
3
First Observation
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Investigator(s): Barbara M Frazier