Biose Industrie 

The inspection of Biose Industrie's facility in Aurillac, France, conducted from October 15 to 17, 2024, revealed significant non-conformities and deficiencies. A letter dated December 20, 2024, notified the establishment of these issues, which were not satisfactorily resolved by January 10, 2025. The ANSM issued a warning to Biose Industrie regarding several areas of concern: - Ineffective deviation management - Systematic failures in data integrity and traceability - Unresolved requalification issues for equipment and facilities used in active substance production - Continued production of a precursor despite rejected validation procedure The ANSM instructed Biose Industrie to implement corrective actions within specific timeframes, including: * Establishing an effective deviation management system (2 months) * Implementing measures to address data integrity issues in automated systems (6 months) * Conducting requalifications for equipment and facilities used in precursor production (6-9 months) * Finalizing validation of the precursor production procedure (6 months)