Teva Women's Health, Inc. - November 8, 2010
Issue Date
Nov 08, 2010
Region
Central
Category
Drug
$117.00
Address 1
5040 Duramed Rd.
City
Cincinnati
State
OH
Zip/Postal Code
45213-2520
Country
US
Inspection Range
Oct 25, 2010 - Nov 08, 2010
Pages
3
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): Anna M. Brannen, Tracey L. Harris, and Christopher T. Middendorf