West-Ward Pharmaceutical Corp. - June 30, 2011
Issue Date
Jun 30, 2011
Region
Central
Category
Drug
$117.00
Contact Name
Elizabeth A. Marro
Contact Title
Vice President, Quality Unit
Address 1
465 Industrial Way West
City
Eatontown
State
NJ
Zip/Postal Code
07724-2209
Country
United States
Inspection Range
Jun 13, 2011 - Jun 30, 2011
Pages
9
First Observation
Control procedures are not established which monitor the output and 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): Paul C. Mouris and Addam S. Reynolds