French Manufacturing Plant Suspended

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] In mid-November, France’s National Agency for Medicines and Health Products Safety (ANSM) suspended operations at contract manufacturer Catalent’s softgel manufacturing facility in Beinheim, France.  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. Based on its preliminary investigation, Catalent believes “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.”  The firm reports that it has notified the appropriate French law enforcement authorities of the incidents, and that it is “cooperating fully” with the ANSM during its inspection and investigation.  Catalent reported the suspension and related information in a Form 8-K filing with the US Securities and Exchange Commission (SEC).

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