Excellium Pharmaceutical, Inc. - October 8, 2009
Issue Date
Oct 08, 2009
Region
Central
Category
Drug
$117.00
Address 1
3 Oak Rd.
City
Fairfield
State
NJ
Zip/Postal Code
7004
Country
US
Inspection Range
Sep 21, 2009 - Oct 08, 2009
Pages
5
First Observation
There is a failure to thoroughly review any unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications whether or not the batch has already been distributed.
Investigator(s): Kelli F. Dobilas