Non-Compliance Report for German Wholesale Distributor Published

Recommendation

20 June 2023
Barcelona, Spain

GMP & GDP Forum 2023
Day 1 only

The competent authority of Germany (Department of Occupational Health and Safety, Customer Protection and Health) has entered a new GPD Non-Compliance Report into the EudraGMDP database due to the discovery of serious GDP non-compliance at a German wholesale distributor.

During an inspection conducted on 18 November 2020, it came out that the company does not comply with the GDP requirements referred to in Article 84 of Directive 2001/83/EC.

"The main reasons were non-GDP-compliant storage conditions without temperature control and access protection or pest control, as well as serious deficiencies in the area of documents (no QMS established, which corresponds to the requirements of the GDP guide). Furthermore, no documentation for the activities carried out could be presented to the inspectors"

As a consequence, the wholesale permission was suspended.

Source: EudraGMDP Database (Inspection Date: 18 November 2020; Report Number: 20200112_G3-6300-GH/B&V) *

* 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.