Catalent’s softgel plant in Beinheim, France received notification from l’Agence National de Sécurité du Médicament et des produits de santé (ANSM) requiring the suspension of manufacturing within the site
Catalent 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.
Catalent is also cooperating fully with the ANSM during its inspection and investigation.
The facility’s quality team has conducted complete risk assessments in accordance with Catalent’s quality management system, including the re-assessment and re-inspection of batches produced during the periods in which these incidents occurred.
Additionally, the site leadership team has implemented, in accordance with the quality management system, significant additional security and access control measures to limit access to products, and they have been reinforcing all relevant policies and procedures with all operators.
The company is now working with the ANSM to determine what additional measures may be necessary to minimise any future occurrence.
