GMT Fine Chemicals, S.A.- Feb.5, 2016
Issue Date
Feb 05, 2016
Region
HQ
Category
Drug
$117.00
Contact Name
Gabriel Haering
Contact Title
CEO and Member of the Board
Address 1
6, rue des Iles
City
Couvet
Zip/Postal Code
2108
Country
Switzerland
Inspection Range
Feb 01, 2016 - Feb 05, 2016
Pages
2
First Observation
You do not have controls in place to ensure that electronic data is unaltered and complete as evidenced by the user access rights assigned to your Analysts and Quality Control Manager for HPLCs utilized to perform in-process testing, raw material testing, finished API testing, and stability testing.
Investigator(s): Angela E. Glenn