GDP-Non-Compliance-Report for German Wholesale Distributor
Register now for ECA's GMP Newsletter
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
17.12.2024GDP in the US: Pre-posting of USP Chapter <1079.2> on MKT
17.12.2024Romanian Authority Issues further GDP Non-Compliance Report
19.11.2024Swissmedic updates Guideline for Conducting Inspections
19.11.2024BioPhorum Article on Resilience of the Supply Chain
19.11.2024Romanian Authority Issues two new GDP Non-Compliance Reports
10.10.2024SwissGMDP Database now available