Amylin Ohio LLC - March 8, 2018
Issue Date
Mar 08, 2018
Region
Central
Category
Drug
$117.00
Contact Name
John Stubenrauch
Contact Title
Executive Director & General manager
Address 1
8814 Trade Port Dr.
City
West Chester
State
OH
Zip/Postal Code
45011-8661
Country
United States
Inspection Range
Mar 05, 2018 - Mar 08, 2018
Pages
2
First Observation
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Investigator(s): Lauren N. Howard, Lianji Jin, and Lindsey M. Schwierjohann