Nephron Pharmaceuticals Corp. - June 17, 2011
Issue Date
Jun 17, 2011
Region
Southeast
Category
Drug
$117.00
Address 1
4121 SW 34th St.
City
Orlando
State
FL
Zip/Postal Code
32811-6475
Country
US
Inspection Range
Jun 07, 2011 - Jun 17, 2011
Pages
13
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): Angela E. Glenn, Carla A. Norris, and Sharon K. Thoma