CSL Behring, LLC - May 23, 2019
Issue Date
May 23, 2019
Region
Central
Category
Drug
$117.00
Contact Name
Michael F. Deem
Contact Title
Sr. VP and General Manager
Address 1
1201 N. Kinzie Avenue
City
Bradley
State
IL
Zip/Postal Code
60915
Country
United States
Inspection Range
May 13, 2019 - May 23, 2019
Pages
4
First Observation
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
Investigator(s): Mihaly S. Ligmond, Randall L. Morris, and Richard T. Riggie