In the event of non-compliance with the provisions of articles L. 513-11-1 and L. 513-11-2 by an establishment or body mentioned in article L. 513-11-1 or in the event of a risk to public health, the Agence nationale de sécurité du médicament et des produits de santé may suspend or prohibit the activities mentioned in article L. 513-11-2.
Except in the case of imminent risk, a decision to suspend or prohibit may only be taken after the establishment or organisation has been given the opportunity to present its observations.