Akorn Operating Co., LLC - May 17, 2022
Issue Date
May 17, 2022
Region
Central
Category
Drug
$117.00
Contact Name
Christopher S. Musser
Contact Title
VP of Operation, Site General Manager
Address 1
72 Veronica Ave.
City
Somerset
State
NJ
Zip/Postal Code
08873-3426
Inspection Range
Apr 18, 2022 - May 17, 2022
Pages
19
First Observation
An NOA-Field Alert Report was not submitted within three working days of receipt of information concerning bacteriological contamination and significant chemical, physical, or other change or deterioration in a distributed drug product.
Investigator(s): Mindy M. Chou, Natasha Gupta, Ko U. Min, Guerlain Ulysse, and Nicholas A. Violand