Novo Nordisk A/S - Nov. 6, 2015
Issue Date
Nov 06, 2015
Region
HQ
Category
Drug
$117.00
Contact Name
Lars G. Karlsen
Contact Title
Senior Vice President, Product Supply/Quality
Address 1
Hallas Alle 1
City
Kalundborg
Zip/Postal Code
4400
Country
Denmark
Inspection Range
Oct 19, 2015 - Nov 06, 2015
Pages
4
First Observation
There is inadequate microbial control during the steps for factor VIl drug substance.
Investigator(s): Debra M. Emerson and Simone E. Pitts