Bayer Health Care, LLC - July 30, 2015
Issue Date
Jul 30, 2015
Region
Southwest
Category
Drug
$117.00
Contact Name
Mark Altman
Contact Title
Vice President Operations, Product Supply AH
Address 1
12707 Shawnee Mission Pkwy.
City
Shawnee
State
KS
Zip/Postal Code
66216-1846
Country
United States
Inspection Range
Jul 21, 2015 - Jul 30, 2015
Pages
1
First Observation
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not written and followed.
Investigator(s): Michele L. Obert