Potential for Malicious Actions within Pharma?


In a November 16 RAPS article by Zachary Brennan he identified that French regulators have suspended production at contract manufacturer Catalent’s softgel capsule manufacturing facility in Beinheim, France.

The company had identified out of place softgel capsules in several product batches during quality control checks.  These were removed.  However Catalent stated that “it is highly unlikely that the capsules could have been misplaced through unintentional human error for from failure of a control process, and that the incidents could be potential related to a deliberate malicious action by one or more individuals.”