Kor-Chem, Inc. - May 5, 2023
Issue Date
May 05, 2023
Region
Southeast
Category
Drug
$117.00
Contact Name
Larry Robertson
Contact Title
Quality Control, Compliance Manager
Address 1
5800 Bucknell Dr. SW
City
Atlanta
State
GA
Zip/Postal Code
30336-2514
Inspection Range
Apr 26, 2023 - May 05, 2023
Pages
10
First Observation
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Investigator(s): Susan O. Oladeji