American Regent, Inc. - Dec. 8, 2022
Issue Date
Dec 08, 2022
Region
Central
Category
Drug
$117.00
Contact Name
Nicklaus Walp
Contact Title
Vice President Quality Affairs
Address 1
6610 New Albany Rd. East
City
New Albany
State
OH
Zip/Postal Code
43054
Inspection Range
Dec 05, 2022 - Dec 09, 2022
Pages
3
First Observation
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
Investigator(s): Joohi Castelvetere and Robert J. Ham