GDP Non-Compliance Report: Spanish Authority Found 29 Deficiencies During an Inspection of a Wholesale Distributor

On 02 July 2026, the competent authority of Spain (Spanish Agency of Medicines and Medical Devices) published a new GDP Statement of Non-Compliance in EudraGMDP.

The statement relates to an inspection of a wholesale distributor conducted on 18 June 2026. According to the statement, a total of 29 deficiencies were identified, of which 8 were classified as critical and 10 as major.

Critical deficiencies were related to the following aspects:

• The management, control and maintenance of the quality system were considered wholly inadequate or non-existent.
• The technical director did not adequately exercise the duties and responsibilities of the role and did not sufficiently supervise delegated functions.
• There was no adequate control of the types of medicines that could be distributed, and no appropriate product classification/registration aligned with distribution activities.

Major deficiencies were also identified in:

• Personnel training management
• Key personnel contingency planning
• Receipt, storage, order picking and dispatch processes
• Warehouse qualification
• Detection and reporting of unusual sales of medicinal products
• Validation of transportation routes
• Technical agreements with outsourced transport providers and their audit/oversight
• Complaint management
• Product recall management

As a regulatory action, the authority ordered the immediate cessation of any medicinal product distribution activities. This measure will remain in place until the deficiencies have been corrected and compliance has been confirmed through a follow-up inspection verifying that an effective quality management system has been implemented and that full GDP compliance has been restored.

Source: EudraGMDP Database (Inspection Date: 2026-06-18; Issue Date: 2026-07-02; Report Number: PCD/NC2601/001/CAT) *

* 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.