A.P. Deauville, LLC - March 4, 2013
Issue Date
Mar 04, 2013
Region
Central
Category
Drug
$117.00
Address 1
594 Jersey Ave.
Address 2
Unit C
City
New Brunswick
State
NJ
Zip/Postal Code
08901-3502
Country
US
Inspection Range
Feb 22, 2013 - Mar 04, 2013
Pages
2
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): Frederick Razzaghi