GlaxoSmithKline - July 24, 2015
Issue Date
Jul 24, 2015
Region
Central
Category
Drug
$117.00
Contact Name
Randy J. Maddux
Contact Title
Site Director
Address 1
9911 Belward Campus Dr.
City
Rockville
State
MD
Zip/Postal Code
20850
Country
United States
Inspection Range
Jul 20, 2015 - Jul 24, 2015
Pages
2
First Observation
The suitability of the reference standard used for the release and stability testing of Drug Substance [REDACTED] has not been adequately qualified.
Investigator(s): M Gutierrez Lugo, Richard A. Lyght, F Namuswe, Thuy Thanh Nguyen, Zhihao Peter Qiu, and Michael R. Shanks