GDP-Non-Compliance-Report for German Wholesale Distributor
The Competent Authority of Germany (Bezirksregierung Düsseldorf) has entered a new GPD Non-Compliance Report into the EudraGMDP database due to serious GDP violations at a German wholesaler located in Mülheim an der Ruhr.
During an inspection conducted on 05 March 2021, it came out that the company does not comply with the GDP requirements referred to in Article 84 of Directive 2001/83/EC.
In the Non-Compliance-Report, the following violations, among others, are listed:
- Trading of falsified medicinal products
- Storage of expired medicinal products in regular stock
- Missing connection to the securepharm-system
- Doubtful reliability of the Reponsible Person and the CEO due to an ongoing criminal procedure
Source: EudraGMDP Database (Inspection Date: 5 March 2021; Report Number: 1 / Document Reference Number: 21130) *
* 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