GlaxoSmithKline LLC - Sept. 11, 2018
Issue Date
Sep 11, 2018
Region
Northeast
Category
Drug
$117.00
Contact Name
Duncan Wardle
Contact Title
Site Director
Address 1
3169 Route 145
City
East Durham
State
NY
Zip/Postal Code
12423-1416
Country
United States
Inspection Range
Aug 30, 2018 - Sep 11, 2018
Pages
4
First Observation
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Investigator(s): Rajiv R. Srivastava