GlaxoSmithKline Biologicals - Oct. 2, 2014
Issue Date
Oct 02, 2014
Region
HQ
Category
Drug
$117.00
Contact Name
Thibaud Stoll
Contact Title
Vice President, Belgium Industrial Operations
Address 1
Parc de la Noire Epine Ave.
Address 2
Fleming 20
City
B-1300 Wavre
Country
Belgium
Inspection Range
Sep 10, 2014 - Oct 02, 2014
Pages
13
First Observation
Inadequate Quality Unit Oversight since 2007 to identify adverse trend of molds, investigate adverse trends, and implement corrective actions to prevent recurrences of molds in the manufacturing environment.
Investigator(s): Debra M. Emerson, Dino A. Feigelstock, and Omotunde O. Osunsanmi