Catalent Reports Action to Restart Softgel Facility

Catalent announced on Nov. 17, 2015 that the company was working with French authorities to resolve an issue with out-of-place softgel capsules in several batches that resulted in the suspension of manufacturing at the company’s Beinheim, France facility. The suspension was announced on Nov. 13 following a notification from the National Security Agency of Medicines and Health Products (ANSM), the pharmaceutical regulatory agency in France.

In a statement, Catalent reported that out-of-place softgel capsules were detected in several product batches during quality control procedures and removed prior to distribution to patients.  Based on a preliminary investigation, the company reports “that it is highly unlikely that the capsules could have been placed incorrectly through unintentional human error or from failure of a control process, and that the incidents could be potentially related to a deliberate action by one or more individuals.”

The company has notified law enforcement authorities of the incidents, filed a written complaint, and is cooperating with the ANSM during its inspection and investigation. In addition, the facility’s quality team has conducted risk assessments, including the re-assessment and re-inspection of batches produced during the periods in which these incidents occurred. Additional security and access control measures have been implemented to limit access to products, the company reports.

“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 company reported in a press statement.

The Beinheim site, one of 11 softgel manufacturing facilities operated by the company, has developed and manufactured softgel capsules since 1965 and produces over 2 billion doses per year. In the last two years, the facility has been subject to seven local and international regulatory inspections with no critical observations, the company reports in a statement.

Source: Catalent, Inc.
US Security and Exchange Commission filing