Glaxo Wellcome Manufacturing Pte Limited - June 1, 2018
Issue Date
Jun 01, 2018
Region
HQ
Category
Drug
$117.00
Contact Name
Lim Hock Heng
Contact Title
VP & Managing Director
Address 1
1 Pioneer Sector 1
City
Singapore
Zip/Postal Code
628413
Country
Singapore
Inspection Range
May 28, 2018 - Jun 01, 2018
Pages
2
First Observation
Your Quality Control (QC) Laboratory failed to establish adequate controls over Empower 3 chromatography data system used to operate the GC and HPLC instruments and to acquire and manage the analytical data.
Investigator(s): Jose E. Melendez