French Regulator Suspends Manufacturing at Catalent Facility
France’s National Security Agency of Medicines and Health Products has ordered Catalent to suspend manufacturing at a facility in Beinheim, France, following the discovery of out-of-place softgels in a number of batches.
In an SEC filing, the drugmaker says it believes the incidents could be related to a “deliberate malicious action” by one or more individuals and not the result of unintentional error or failure of a control process. The batches containing the incorrect softgel capsules were detected before distribution, the company says.
In the wake of the discovery, the company has added security and access control measures and reinforced “all relevant policies and procedures with all production personnel” to ensure adherence to Catalent standards.
Catalent adds that it is working with ANSM to ensure compliance, and the duration of the suspension is unknown.