June Jacobs Labs, LLC - March 21, 2011
Issue Date
Mar 21, 2011
Region
Central
Category
Drug
$117.00
Address 1
46 Graphic Pl.
City
Moonachie
State
NJ
Zip/Postal Code
07074
Country
US
Inspection Range
Feb 09, 2011 - Mar 21, 2011
Pages
8
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 an in-process material and the drug product.
Investigator(s): Stephen Mottola and Barbara J. Wilimczyk-Macri