Catalent has suspended manufacturing at a softgel facility in Beinheim, France after it received a notification from l’Agence National de Sécurité du Médicament et des produits de santé (ANSM), the primary French pharmaceutical regulatory agency, about “out-of-place” softgel capsules in several product batches that were detected during quality control procedures and removed prior to distribution to patients.

Catalent says it is highly unlikely that the capsules could have been misplaced through unintentional human error or from the failure of control processes, and that the incidents could be related to deliberate actions by one or more individuals. The company has notified law enforcement authorities by filing a written complaint to the prosecutor of the civil court in Strasbourg.

According to Catalent, there were two sets of incidents at the Beinheim site. The first was in July 2015, after which the company conducted rigorous risk assessments, only releasing affected batches after re-inspections of the affected batches. “Corrective actions were also put in place at the time, and these appear to have been effective in preventing recurrence in that particular part of the operation,” said Sharon Johnson, senior vice president of quality, product development and regulatory affairs, Catalent. “The more recent incidents occurred earlier in the production process, and in a different area. Corrective action steps are now being taken to mitigate the risk of future occurrences there, too.”

At the time of the first incidents, Catalent believed that its quality processes had uncovered all the misplaced capsules and that the additional security measures implemented were sufficient to resolve the identified incidents within the facility. The company had no firm evidence of deliberate action at that time, and no further occurrences or complaints occurred for approximately 2½ months after the July incidents. As soon as the second set of occurrences happened, Catalent reopened their own investigations and contacted the appropriate law enforcement authorities.

Other than saying it conducts regular cGMP (current good manufacturing practice) training for all staff, the company would not speculate on why someone would deliberately act in breach of quality standards.

Unable to say when production at the plant will resume, the company is working with customers to address all aspects of this situation and any supply chain interruptions.

“Our principal priority is the safety of patients, and we take all matters related to the quality and supply of our products extremely seriously,” said Ms. Johnson. “We are working diligently with all customers of the Beinheim site and the relevant authorities in order to resolve the situation as quickly as possible.”

Catalent’s Beinheim site has developed and manufactured capsules since 1965. It is one of eleven softgel manufacturing facilities in Catalent’s worldwide manufacturing network. It currently has thirty-one sites overall.