Akorn, Inc. - May 31, 2018
Issue Date
May 16, 2018
Region
Central
Category
Drug
$117.00
Contact Name
Jonathan D. Shoemaker
Contact Title
Vice President and General Manager
Address 1
1222 W. Grand Ave.
City
Decatur
State
IL
Zip/Postal Code
62522
Country
United States
Inspection Range
Apr 09, 2018 - May 16, 2018
Pages
24
First Observation
Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes.
Investigator(s): Michele L. Glendenning, Sandra A. Hughes, and Michele Perry-Williams