APP Pharmaceuticals, LLC - July 8, 2011
Issue Date
Jul 08, 2011
Region
Northeast
Category
Drug
$117.00
Address 1
3159 Staley Rd.
City
Grand Island
State
NY
Zip/Postal Code
14072-2028
Country
US
Inspection Range
Jun 13, 2011 - Jul 08, 2011
Pages
18
First Observation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Investigator(s): James D. Bridges, Kevin A. Gonzalez, and Felix Maldonado