Fougera Pharmaceuticals, Inc. - 2/1/2012
Issue Date
Feb 01, 2012
Region
Northeast
Category
Drug
$117.00
Address 1
55 Cantiague Rock Road
City
Hicksville
State
NY
Zip/Postal Code
11801
Country
United States
Inspection Range
Jan 17, 2012 - Feb 01, 2012
Pages
1
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): James A. Liubicich