Ortho Pharmaceutical - June 28, 2010
Issue Date
Jun 28, 2010
Region
Southeast
Category
Drug
$117.00
Address 1
45.6 Carr 2
Address 2
Bo. Campo Alegre
City
Manati
Zip/Postal Code
00674-0463
Country
PR
Inspection Range
Jun 16, 2010 - Jun 28, 2010
Pages
3
First Observation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of it's components to meet any of its specifications whether or not the batch has been already distributed.
Investigator(s): Noreen Muniz