Pharmaloz Manufacturing, Inc. - January 20, 2011
Issue Date
Jan 20, 2011
Region
Central
Category
Drug
$117.00
Address 1
500 N. 15th Ave.
City
Lebanon
State
PA
Zip/Postal Code
17046-8303
Country
US
Inspection Range
Jan 14, 2011 - Jan 20, 2011
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): Susan E. Polifko