GRI

Injunction n ° 2025-BPL-003-Inj relating to the Icare test installation located in Martillac (33) at 14 allée Jacques Latrille

Enforcement Healthcare & Pharma Reports
Date: 7th May, 2025 Source: French National Agency for the Safety of Medicines and Health Products (ANSM) Country: France Original Source

Brief

The inspection of the Icare testing facility in Martillac, France, from February 3 to 7, 2025, revealed significant non-conformities and shortcomings. The French National Agency for Medicine and Health Products Safety (ANSM) issued a preliminary injunction letter on March 7, 2025, citing several areas of concern, including audit failures, quality assurance program breaches, and unaddressed impacts on study conformity. The ANSM ordered Icare to address these issues within specific timeframes: conducting audits, ensuring environmental conditions in testing facilities, presenting microbiological test results, implementing cleaning and disinfection procedures, and controlling water quality. Failure to comply may result in further action.

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

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