13/14 December 2023
The Spanish Agency Of Medicines And Medical Devices has added a new GDP Non-Compliance Report dated 31 August 2023 to the EudraGMDP database. During an inspection of a wholesale distributor located in Fuenlabrada, a series of deviations from Good Distribution Practice were found.
In the report, the authority addresses findings in the following areas:
The authority writes that the following wholesale distribution activities are effected: "Procuring, holding, supplying and storage by contract of medicines for human use, with marketing authorization in the EEA country(ies), for psychotropic, narcotic, blood-derived, immunological, thermolabile, veterinary, immunosuppressive and cytostatic medicines."
The deviations found led to a suspension of the company's authorisation.
Source: EudraGMDP Database (Inspection Date: 27 July 2023; Report Number: IIBPD/FRG/20230811). *
* 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.