Hikma Pharmaceuticals USA, Inc. - Nov. 22, 2023
Issue Date
Nov 22, 2023
Region
Central
Category
Drug
$117.00
Contact Name
Omar Alkhrisat
Contact Title
General Manager
Address 1
2 Esterbrook Ln.
City
Cherry Hill
State
NJ
Zip/Postal Code
08003-4002
Inspection Range
Oct 23, 2023 - Nov 03, 2023
Pages
6
First Observation
Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed.
Investigator(s): Sean R. Marcsisin and Lori M. Newman