GDP-Non-Compliance-Report for German Wholesale Distributor

Recommendation
Wednesday, 30 April 2025 9 .00 - 17.30 h
How to Audit Logistics Service Providers
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
11.03.2025USP Publishes Summary of Comments on Chapter <1079.2> Regarding Mean Kinetic Temperature (MKT)
11.03.2025EMA: No further Extension of GDP Certificates in 2025
11.03.2025Aide-Mémoires and Checklists in GDP Audits - Benefits and Risks
13.02.2025MHRA updates Guidance on Sourcing Medicines for the UK Market
13.02.2025First GDP Non-Compliance Report of 2025: Data Integrity Issues at Hungarian Wholesaler