GDP Non-Compliance Report for Austrian API Distributor
Recommendation
Thursday, 5 June 2025 9 .00 - 13.15 h
Register now for ECA's GMP Newsletter
The Austrian Agency for Health and Food Safety has entered a new GDP Non-Compliance Report dated 07 December 2023 into the EudraGMDP database. During an inspection, it came out that an active substance (API) distributor located in Vienna does not comply with the GDP principles for active substances.
The authority writes that "all registered active substances distributed are affected" and that "concerned member states are informed".
The Wholesale Distribution Authorisation (WDA) was withdrawn.
Source: EudraGMDP Database (Inspection Date: 31 August 2023; Report Number: 481791-101212189). *
* To find the respective report, please click on "Non-Compliance Reports" in the menu on the left-hand side and select in "From Date / To Date" the month the inspection took place. After clicking on "Search" the results list will be displayed, from which you can choose the report with the number mentioned above.
Related GMP News
14.05.2025Stimuli Article Proposes Revision of USP Definition of Controlled Room Temperature (CRT)
13.05.2025Survey on GDP Implementation
13.05.2025New Version of the HPRA GDP Guide Published
13.05.2025GDP in the US: Updates on Implementation of DSCSA
13.05.2025GDP Non-Compliance Report: No Responsible Person, proper Storage and Distribution not ensured
13.05.2025Questions and Answers from the ECA Webinar "GDP Update 2025" - Part 2