GRI

Injunction n ° 2024_MEDCHIM_142_inj of 03/06/2025 relating to the establishment of the CENEXI company located in Fontenay-sous-Bois (Val-de-Marne), 52 rue Marcel and Jacques Gaucher

Enforcement Healthcare & Pharma Reports
Date: 17th Jun, 2025 Source: French National Agency for the Safety of Medicines and Health Products (ANSM) Country: France Original Source

Brief

The inspection report highlights significant non-conformities and shortcomings at CENEXI's manufacturing facility. Noted issues include degraded facilities, inadequate maintenance, deficient cleaning operations, and unsatisfactory management of aseptic processes, documentation, and personnel training. The ANSM orders Cenexi to take corrective measures within specified deadlines to address these issues, including improving facility conditions, implementing robust maintenance management, and enhancing aseptic process simulation, product inspection, and microbiological control.

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

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