Capsugel - Feb. 17, 2010
Issue Date
Feb 17, 2010
Region
HQ
Category
Drug
$117.00
Contact Name
Sam MacHour
Contact Title
Director, Quality and Compliance Operations
Address 1
Z.I. De Camagnon BP 320
City
Ploermel
Zip/Postal Code
56800
Country
France
Inspection Range
Feb 15, 2010 - Feb 17, 2010
Pages
2
First Observation
Control procedures are not established which monitor the output of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Investigator(s): Luis M. Burgos Medero and Michael A. Charles