Primary source: ANSM (France) - News feed
Translated From French
PV Bulletin does not take any responsibility for translation errors or omissions, though it has used the best available translation engine.
Surgifrance is mandated to rectify identified non-conformities, secure all required regulatory documents before marketing, and establish required processes within specified timelines.
This injunction is crucial for ensuring compliance with regulatory requirements, enhancing product safety, and preparing the establishment for upcoming inspections.
Surgifrance must implement corrective actions, including the establishment of processes for handling complaints in 3 months, and a complaints register within 8 months.
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Surgifrance must implement corrective actions, including the establishment of processes for handling complaints in 3 months, and a complaints register within 8 months.
The French national drug safety agency (ANSM) issued an injunction to Surgifrance requiring immediate corrective actions to enhance regulatory compliance and inspection readiness, including the establishment of verification processes, a complaints register, and a system for handling complaints and vigilance.
What changed: Surgifrance is mandated to rectify identified non-conformities, secure all required regulatory documents before marketing, and establish required processes within specified timelines.
Why it matters: This injunction is crucial for ensuring compliance with regulatory requirements, enhancing product safety, and preparing the establishment for upcoming inspections.
Practical implication: Surgifrance must implement corrective actions, including the establishment of processes for handling complaints in 3 months, and a complaints register within 8 months.
Published from the regulator source ingestion pipeline after PV impact triage.
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Affected users must identify, segregate, and quarantine the kits, add warning labels, and ensure the removal of the recalled components prior to use.
