Hikma Pharmaceuticals USA, Inc. - Sept. 10, 2019
Issue Date
Sep 10, 2019
Region
Central
Category
Drug
$117.00
Contact Name
Anibal Carlo
Contact Title
Vice President, US Injectables Manufacturing
Address 1
2 Esterbrook Ln.
City
Cherry Hill
State
NJ
Zip/Postal Code
08003-4002
Country
United States
Inspection Range
Aug 27, 2019 - Sep 10, 2019
Pages
2
First Observation
There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Investigator(s): Yvesna Blaise