Octapharma AB - July 14, 2016
Issue Date
Jul 14, 2016
Region
HQ
Category
Drug
$117.00
Contact Name
Alex Scheepers
Contact Title
General Manager
Address 1
SE-112 75
City
Stockholm
Country
Sweden
Inspection Range
Jun 07, 2016 - Jun 14, 2016
Pages
1
First Observation
The investigation of out-of-inspection (OOS) results in the stability studies under licensed conditions is deficient in that it failed to identify both the route cause(s) that led to the OOS results and effective and preventative actions (CAPA) to remedy the problem.
Investigator(s): Anthony Lorenzo and Andrey Sarafanov