Bayer Healthcare - Dec. 13, 2016
Issue Date
Dec 13, 2016
Region
Pacific
Category
Drug
$117.00
Contact Name
Jay T. Benson
Contact Title
VP, Head of Supply Center
Address 1
800 Dwight Wy.
City
Berkley
State
CA
Zip/Postal Code
94710
Country
United States
Inspection Range
Nov 29, 2016 - Dec 13, 2016
Pages
3
First Observation
There is a failure to complete established and scheduled Preventative Maintenance due dates of equipment used for the manufacture of Kovaltry intermediates and Drug Substance in a timely manner.
Investigator(s): James C. Lee and Stephanie A. Slater