Bayer Healthcare LLC - June 19, 2009
Issue Date
Jun 19, 2009
Region
Pacific
Category
Drug
$117.00
Address 1
800 Dwight Way
City
Berkeley Springs
State
CA
Zip/Postal Code
94701
Country
US
Inspection Range
Jun 09, 2009 - Jun 19, 2009
Pages
4
First Observation
The procedures that specify initiating QA investigations in response to Adverse events and Product Technical Complaints do not specifically state the requirements for Lot/Batch Investigations, Lot Packet Reviews, or Batch Production Reviews and when they are to be conducted.
Investigator(s): Prabhu P. Raju and Helen B. Ricalde