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Actionable news in CTLT: CATALENT Inc,

On November

lAgence National de Scurit du Mdicament et des produits de sant

(ANSM), the primary French pharmaceutical regulatory agency, requiring the suspension of manufacturing at the site. The Beinheim site is one of eleven softgel manufacturing facilities in Catalents worldwide manufacturing network; Catalent currently has thirty-one sites overall. Catalent takes all matters related to the quality and supply of its products extremely seriously and has been working diligently with all relevant authorities in order to resolve the circumstances leading to the suspension as quickly as possible.

The suspension relates to 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. B ased on its preliminary investigation of this matter, Catalent believes that it is highly unlikely that the capsules could have been misplaced through unintentional human error or from failure of a control process, and that the incidents could be potentially related to a deliberate malicious action by one or more individuals. Catalent has notified the appropriate French law enforcement authorities of the incidents by filing a written complaint. Catalent is also cooperating fully with the ANSM during its inspection and investigation.

In accordance with Catalents standard continuous process improvement and quality management deviation review systems, facility quality personnel conducted risk assessments of these incidents, including the re-assessment and re-inspection of batches produced...


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