IDT Biologika Gmbh - Dec. 9, 2014
Issue Date
Dec 09, 2014
Region
HQ
Category
Drug
$117.00
Contact Name
Ralf Pfirmann
Contact Title
Chief Executive Officer
Address 1
Am Pharmapark
Address 2
Dessau-Rossisu
City
Dessau-Rossisu
Zip/Postal Code
6861
Country
Germany
Inspection Range
Dec 01, 2014 - Dec 09, 2014
Pages
6
First Observation
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control receipts or other records are instituted only by authorized personnel.
Investigator(s): Kim Thomas Cruse and Victoria A. Wagoner