Catalent suspends production at site in Beinheim, France
After discovery of 'out-of-place' softgel capsules in incidents that could be 'deliberate malicious action' by one or more individuals
US based dosage forms speciaiist Catalent has suspended production at a softgel manufacturing plant in Beinheim, France at the request of the French regulator l’Agence National de Sécurité du Médicament et des produits de santé (ANSM).
The firm said it had discovered several 'out-of-place softgel capsules in several product batches' during quality control checks at the plant in the Alsace region.
Based on its preliminary investigations, Catalent believes that it is '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'.
The company said it is working with French law enforcement authorities and ANSM to find out what happened.
The firm has discovered several 'out-of-place softgel capsules in several product batches'
In accordance with Catalent’s standard procedures, quality personnel at the site conducted risk assessments of these incidents, including the re-assessment and re-inspection of batches produced during the periods in which these incidents occurred. As part of this process, Catalent has implemented 'significant additional security and access control measures to limit access to products'.
Catalent is also working with ANSM to see if any additional measures need to be taken to aid in preventing any future occurrence and has assembled a team of experts to provide full support to speed up the resolution of the problem.
The company said it did not know how long production would be on hold at the plant and will work with customers to deal with any interruption in supplies.
The Beinheim site is one of 11 softgel manufacturing facilities in Catalent's worldwide manufacturing network. It has developed and manufactured softgel capsules since 1965, produces more than two billion doses every year, and has an excellent regulatory track record, the firm said.
In the last two years, the facility has had seven local and international regulatory inspections with no critical observation, as well as two dozen customer audits conducted as a part of those clients’ Supplier Quality Assurance programmes.
