Janssen Biotech, Inc. - June 15, 2012
Issue Date
Jun 15, 2012
Region
Central
Category
Drug
$117.00
Address 1
200 Great Valley Pkwy.
City
Malvern
State
PA
Zip/Postal Code
19355
Country
US
Inspection Range
May 31, 2012 - Jun 15, 2012
Pages
3
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 been already distributed.
Investigator(s): Susan Hadman and Julianne C. McCullough