Catalent, at the request of France's top pharma regulator ANSM, halted production at a softgel plant on Friday after it reported to them that it had twice found "out-of-place" capsules in batches and suspected tampering.
In a public filing passed to FiercePharma by the company, Catalent ($CTLT) 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. 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 in the filing. "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."
The first incident was discovered in July and the second in October, according to Elliott Berger, VP of global marketing and strategy for the company, who spoke by phone on Monday.
"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 wouldn't 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 initial 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 contract drug developer and manufacturer said it put into 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.
Unable to say when the plant will resume production, the company is working with clients to deal with supply chain interruptions. It said the ANSM will allow clients to get their products if they can show that "their" systems also are capable of detecting any out-of-place products.
Two years ago French 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