Bayer Healthcare Pharmaceuticals, Inc. - May 24, 2013
Issue Date
May 24, 2013
Region
Pacific
Category
Drug
$117.00
Contact Name
Olivia M. Krampe
Contact Title
VP Head of Supply Center Emeryville
Address 1
5650 Hollis St.
City
Emeryville
State
CA
Zip/Postal Code
94608-2505
Country
United States
Inspection Range
May 13, 2013 - May 24, 2013
Pages
4
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 it specifications whether or not the batch has been already distributed.
Investigator(s): Lynda L. Perry, Daniel J. Roberts, and Rebeca Rodriguez