On Friday, France’s health regulator - l’Agence National de Sécurité du Médicament et des produits de santé (ANSM) – suspended manufacturing at Catalent’s softgel development and production site in Beinheim, about 40km north of Strasbourg.
“The suspension relates to the occurrence of out-of-place softgel capsules in several product batches that were detected during quality control procedures and removed prior to distribution to patients,” the contract development and manufacturing organisation (CDMO) said in an SEC filing.
“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.”
As such, the firm has notified the appropriate French law enforcement agencies and begun efforts to overturn the ban at the site, which has the capacity to produce up to 4.5 billion capsules per year.
“The facility’s quality team has conducted complete risk assessments in accordance with Catalent’s quality management system, including the re-assessment and re-inspection of batches produced during the periods in which these incidents occurred.”
Catalent did not immediately respond to requests for more information, but according to William Blair analyst John Kreger and disruption should be modest.
“There were fewer than 20 capsules discovered to be in the wrong batches out of a total annual production size of about 2 billion capsules,” he said in a note. “The company's quality control process caught all but one of these errors; the final batch was caught by a client before shipment to patients.”
Furthermore, as it is believed human tampering was the cause and not the firm’s manufacturing processes, Kreger added “the remedy should be fairly straightforward (more surveillance and less access to finished product) and thus the suspension will most likely be short lived.”
Pharma Tampering
If deliberate human actions are to blame, Catalent would not be alone among drugmakers which have fallen victim to such crime.
Last year, GSK recalled batches of its weight-loss OTC drug Alli after discovering a number of bottles had been tampered with, and Roche pulled nine batches of its breast cancer drug Herceptin after discovering tampered vials in the UK, Finland and Germany.
And in 2013, ANSM ordered pharmacists to stop selling Teva’s drug Furosemide after a number of deaths were believed to have been caused by deliberate mislabelling of the product with the sleeping pill Zopiclone.