Fresenius Kabi USA, LLC - June 30, 2022
Issue Date
Jun 30, 2022
Region
Central
Category
Drug
$117.00
Contact Name
Ricky D. McCleskey
Contact Title
Plant Manager
Address 1
2020 N. Ruby St.
City
Melrose Park
State
IL
Zip/Postal Code
60160-1112
Inspection Range
May 18, 2022 - Jun 30, 2022
Pages
15
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 already distributed.
Investigator(s): Nicholas P. Diorio, Brian D. Nicholson, Joseph Piechocki, and Nibin Varghese