Catalent’s softgel plant in Beinheim, France, received a notification from l’Agence National de Sécurité du Médicament et des produits de santé (ANSM) requiring the suspension of manufacturing within the site.
Catalent said it has been investigating the occurrence of out-of-place softgel capsules in several product batches that were detected during quality control procedures and removed prior to distribution to patients. The company’s preliminary investigation indicates that it is highly unlikely that the capsules could have been placed incorrectly through unintentional human error or from failure of a control process, and that the incidents could be potentially related to a deliberate action by one or more individuals.
Catalent has subsequently notified the appropriate law enforcement authorities of the occurrence of the incidents by filing a written complaint. The company is also cooperating fully with the ANSM during its inspection and investigation.
The Beinheim site has developed and manufactured softgel capsules since 1965, produces over 2 billion doses every year, and has an excellent regulatory track record, the company says.
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