Brief

The French National Agency for Medicines and Health Products Safety (ANSM) conducted an inspection at Galderma International's establishment in La Défense, highlighting significant non-conformities and shortcomings. Notified on April 11, 2025, the issues included unauthorized promotion of botulinum toxin-based medications to general practitioners, insufficient qualification and registration processes for these products, and critical gaps in monitoring transactions related to them. The ANSM ordered Galderma International to take immediate compliance action within specific deadlines, including revising marketing practices, implementing detailed visit reports, qualifying and registering product recipients, and establishing robust transaction surveillance.

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French National Agency for the Safety of Medicines and Health Products (ANSM)

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