Ebewe Pharma Ges MBH Mfg. KG - 7/25/2011
Issue Date
Jul 25, 2011
Region
Central
Category
Drug
$117.00
Address 1
Mondseestrasse 11
City
Unterach am Attersee
Zip/Postal Code
A-4866
Country
Austria
Inspection Range
Jul 15, 2011 - Jul 25, 2011
Pages
6
First Observation
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.
Investigator(s): Carla J. Lundi and Parul M. Patel