U.S.-based Catalent ($CTLT) has halted production at a softgel capsule manufacturing facility in France at the request of regulators after several incidents in which it appears someone within the plant purposely mixed the wrong capsules into batches. The company said it is working with French law enforcement and regulators to find out what happened.
Catalent, in a public filing it passed to FiercePharma, said the incident occurred at a plant in Beinheim, France, which is about 510 kilometers from Paris. It said the "out-of-place" capsules were detected during quality control procedures and removed before they were shipped to patients. The suspension was requested by France's top pharma regulator, the ANSM, on Friday. Catalent said it is working with "all relevant authorities" to determine who and why someone apparently sabotaged production.
"Based on its preliminary investigation of this matter, 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 today in a public filing which it passed to FiercePharma. "Catalent has notified the appropriate French law enforcement authorities of the incidents by filing a written complaint. Catalent is also cooperating fully with the ANSM during its inspection and investigation."
Elliott Berger, Catalent VP of global marketing & strategy, in a phone interview today said that the first incident was discovered in July and that a second incident was found in October. "The important thing to remember is that the system is designed to detect these things and it worked. We had another incident and it worked again," Berger said. "That is why we checked all down the line, at labeling and packaging."
Berger said he could not speculate as to why someone would do something like this. While the suspension was requested on Friday, the same day that terrorists initiated attacks in Paris, Berger emphasized the first incident was detected in July, well ahead of France's current security concerns. "I can't say why someone might do this but it could be any number of things, employment cessation, anything. These are human beings. But the system worked and caught it."
The company said that it has no ideas at this point how long production will be on hold and that it will work with clients to deal with any interruption in supplies. It said the ANSM will allow clients to get already manufactured products if they can show that "their" systems also are capable of detecting any out-of-place capsules before they would get to patients.
The contract drug development and manufacturer says that it has clapped in place "significant additional security and access control measures to limit access to products" at the plant in France. It has also brought in experts from its organization and has reinforced oversight of production. Because the processes which Catalent uses throughout its 31-plant manufacturing network proved effective, Berger said the company has not felt the need to do anything special at any of its other facilities.
It was also in France two years ago that regulators investigated, and cleared of any wrongdoing, a Teva Pharmaceutical Industries ($TEVA) facility after some blister packs of Teva meds were found to contain sedatives instead of the diuretic medicine they were supposed to contain.
- here's the filing