Alliance Packaging Group, Inc. - Dec. 4, 2014
Issue Date
Dec 04, 2014
Region
Central
Category
Drug
$117.00
Contact Name
Linda J. Kamel
Contact Title
President
Address 1
420 Technology Way
City
Saukville
State
WI
Zip/Postal Code
53080-1677
Country
United States
Inspection Range
Dec 02, 2014 - Dec 04, 2014
Pages
3
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): Rafael A. Kaup and Ivan E. Reyes