Catalent Pharma Solutions - June 10, 2011
Issue Date
Jun 10, 2011
Region
HQ
Category
Drug
$117.00
Address 1
Font Saint Landry, 10
City
Brussels
Zip/Postal Code
B-1120
Country
BE
Inspection Range
Jun 01, 2011 - Jun 10, 2011
Pages
5
First Observation
Failure investigations and/or corrective and preventive action procedures are incomplete for validated processes designed to prevent microbiological contamination of biological equipment purporting to be sterile.
Investigator(s): Paul Bonneau, Burnell M. Henry, and Christian D. Lynch