Catalent reports that its softgel manufacturing 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. The company received the notice on November 13, 2015. Catalent said it is cooperating fully with the ANSM during its inspection and investigation.

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 in order to ensure utmost vigilance and compliance with Catalent's established processes. The company is now working with the ANSM to determine what additional measures may be necessary to minimize any future occurrence. Catalent has assembled resources and experts from around its global quality and manufacturing organizations to provide full support in expediting the resolution of this issue.

The Beinheim site has developed and manufactured softgel capsules since 1965, produces over 2 billion doses every year, and has an strong egulatory track record. The site has more than 300 employees. In the last two years, the facility has been subject to seven local and international regulatory inspections with no critical observation, as well as two dozen customer audits conducted as a part of those clients' supplier quality assurance programs.

Source: Catalent