Brief

The inspection of Martin Dow Pharmaceuticals' establishment in Meymac (Corrèze) revealed significant non-conformities and shortcomings. Notified to the company on November 22, 2024, these issues were still unresolved as of January 14, 2025. The ANSM has ordered Martin Dow Pharmaceuticals to address these issues by implementing necessary resources and organization to investigate and correct complaints and deviations within six months, establishing a sufficient training system for operators also within six months, reorganizing the facility within nine months, conducting required qualifications, validations, and maintenance within twelve months, and evaluating and managing cross-contamination risks within twelve months.

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

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