GRI

Injunction n ° 2025-GCP-001 on the northern cardiological center located in Saint-Denis (93) at 32-36 rue des Moulins Gemini

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 Centre Cardiologique du Nord in Saint-Denis revealed significant nonconformities and shortcomings. A letter was sent to the establishment on March 24, 2025, highlighting insufficiencies in document tracing, access to electronic documentation, and inconsistencies in source documents. The French National Agency for Medicines and Health Products Safety (ANSM) has ordered the Centre Cardiologique du Nord to implement corrective actions within specified deadlines, including updating their software systems and documentation to ensure compliance with Good Clinical Practices regulations.

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

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