German Authority releases new GDP Non-Compliance Report

The competent authority in Germany (Bezirksregierung Koeln) has issued a new GDP Non-Compliance Report in the EudraGMDP database. A reinspection of a wholesale distributor in Cologne on April 18, 2024, revealed that issues from the previous inspection on October 19, 2023, remained unresolved, with additional critical and serious findings identified. The company, involved in the procurement, storage, supply, export, and transport of human medicinal products, was found non-compliant with Good Distribution Practice (GDP) standards. Key concerns included deficiencies in customer and supplier qualification systems, verification checks, transportation practices, documentation, and outsourced activities. Consequently, the company's wholesale distribution authorization was suspended on January 2, 2024, and revoked on July 17, 2024.