GDP Non-Compliance Report for German Wholesale Distributor: No GDP Conform Quality System and No Suitable and Adequate Premises

Recommendation

1/2 March 2023

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The competent authority of Germany (Bezirksregierung Köln) has entered a new GPD Non-Compliance Report dated 03 December 2021 into the EudraGMDP database. Due to the seriousness of the violations, the Wholesale Distributor Authorisation was revoked.

During an inspection conducted on 29 November 2021, it came to light that the company located in Pulheim-Brauweiler, Germany, does not comply with the GDP requirements referred to in Article 84 of Directive 2001/83/EC.

The authority lists the following four types of violations:

• "no GDP conform quality system
• no suitable and adequate premises, installations and facilities
• no responsible person who possesses the required expert knowledge
• the wholesaler is unable to guarantee that the regulations governing proper operations are being observed"

Source: EudraGMDP Database (Inspection Date: 29 November 2021; Report Number: 24.05.01.17-03-0126) *

* 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.