Troy Manufacturing, Inc. - August 30, 2010
Issue Date
Aug 30, 2010
Region
Central
Category
Drug
$117.00
Address 1
130 Lions Dr.
City
Hazelton
State
PA
Zip/Postal Code
18201
Country
US
Inspection Range
Aug 25, 2010 - Aug 30, 2010
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): Brandi L. Garbutt and Susan E. Polifko