Janssen Ortho, LLC - June 13, 2011
Issue Date
Jun 13, 2011
Region
Southeast
Category
Drug
$117.00
Address 1
Carr #933 Km 0.1
Address 2
Mamey Ward
City
Gurabo
Zip/Postal Code
00778
Country
PR
Inspection Range
Jun 06, 2011 - Jun 13, 2011
Pages
2
First Observation
Investigations of an unexplained discrepancy and a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product.
Investigator(s): Ramon A. Hernandez