Excellium Pharmaceutical, Inc. - 1/23/2012
Issue Date
Jan 23, 2012
Region
Central
Category
Drug
$117.00
Address 1
3 G Oak Rd.
City
Fairfield
State
NJ
Zip/Postal Code
07004
Country
United States
Inspection Range
Jan 04, 2012 - Jan 23, 2012
Pages
4
First Observation
The written stability program for drug products does not include test intervals based on statistical criteria for each attribute examined to assure valid estimates of stability.
Investigator(s): Michael R. Klapal