France’s health product regulator, l’Agence National de Sécurité du Médicament et des produits de santé (ANSM), suspended production at contract manufacturer Catalent’s softgel capsule manufacturing facility in Beinheim, France, on Friday.
The suspension of the site, which the company says it’s unable to predict the duration of, came because of “out-of-place softgel capsules in several product batches that were detected during quality control procedures and removed prior to distribution to patients,” according to an SEC filing from Catalent.
And unlike a routine issue, the company says it believes it’s “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.”
Catalent says it has notified the appropriate French law enforcement authorities of the incidents by filing a written complaint, and it’s also working with ANSM during its inspection and investigation.
Work to be Done
In accordance with its process improvement and quality management deviation review systems, Catalent facility quality personnel conducted risk assessments of these incidents, including the re-assessment and re-inspection of batches produced when the incidents occurred, the company said.
As part of this process, Catalent has implemented significant additional security and access control measures to limit access to products, and it has been reinforcing all relevant policies and procedures with all production personnel.
Catalent is also working with ANSM to determine any additional measure to aid in preventing any future occurrences and the company has assembled resources and experts from its other operations to provide support.
However, Catalent notes that there are two instances in which its customers may apply to ANSM for an exception to the suspension, such as for medicines that must be available in order to continue treatment for patients, if the company can show that controls will prevent distributed medicines from including any out-of-place capsule.
Catalent clients can also apply for an exception for medicines being manufactured on the date of the suspension, if the client can show that their systems, including the systems used to package these medicines for distribution, can detect and exclude any out-of-place capsule.
Catalent SEC Filing