Xellia Pharmaceuticals ApS - May 8, 2018
Issue Date
May 08, 2018
Region
HQ
Category
Drug
$117.00
Contact Name
Niels Murmann
Contact Title
Site Head, Vice President Global API Manufact uring
Address 1
Dalslandsgade 11
City
Copenhagen S
Zip/Postal Code
2300
Country
Denmark
Inspection Range
Apr 30, 2018 - May 08, 2018
Pages
4
First Observation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been aleady distributed.
Investigator(s): Christopher D. Leach