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news.Catalent has halted production at its softgel facility in Beinheim, France due to 'out-of-place' softgel capsules in various product batches.
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The company received notification from French pharmaceutical regulatory agency l’Agence National de Sécurité du Médicament et des produits de santé (ANSM) to suspend manufacturing within the site.
Catalent identified the out-of-place capsules during quality control procedures and removed before they were shipped to patients.
The company’s preliminary investigation suggests that it is highly unlikely that the capsules could have been placed incorrectly through unintentional human error or from failure of a control process.
It is expected that one or more individuals may have deliberately tampered the products.
Catalent said it will work with regulators, government officials and customers to minimize any interruption in supply of medicines to patients.
The Beinheim site has developed and produced softgel capsules since 1965. It manufactures more than 2 billion doses per year.
Catalent provides drug delivery technology and development solutions for drugs, biologics and consumer health products.
The company has about 30 sites globally which make or package more than 100 billion units per year.