Lilly del Caribe, Inc. - Feb. 17, 2023
Issue Date
Feb 17, 2023
Region
Southeast
Category
Drug
$117.00
Contact Name
Nellie D. Clark
Contact Title
Site Head, Bulk Plant
Address 1
400 Fabril St.
City
Carolina
State
PR
Zip/Postal Code
00987
Inspection Range
Feb 08, 2023 - Feb 17, 2023
Pages
4
First Observation
The quality unit failed to thoroughly review any unexplained discrepancy whether or not the drug substance batch has been already distributed.
Investigator(s): Angelica M. Hernandez, Marian E. Ramirez, and Jose Velez