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Regulators Lift Suspension on Catalent Softgel Facility

May 4, 2016
Pharmaceutical Technology Editors

ANSM lifted the suspension on Catalent’s Beinheim, France facility, allowing the company to resume pharmaceutical operations.

On April 28, 2016, Catalent announced that it had received an order from French National Agency for Medicines and Health Products Safety (ANSM) lifting the suspension on its Beinheim, France facility. “The order also reiterates Catalent’s commitment to work with its customers to address raw materials and finished products still present from the pre-suspension period in order to manage any risk of possible product contamination,” the company said in a statement.

Pharmaceutical operations at the facility were suspended on Nov. 13, 2015 when out-of-place softgel capsules were discovered in several batches. In a statement, Catalent reported the out-of-place capsules were discovered in the batches during quality control procedures and were removed prior to distribution to patients. The company filed an official complaint and notified law enforcement officials of the incident. Based on preliminary investigation in November 2015, the company said “it is highly unlikely that the capsules could have been placed incorrectly through unintentional human error or from failure of a control process, and that the incidents could be potentially related to a deliberate action by one or more individuals.”

The Beinheim site, one of 11 softgel manufacturing facilities operated by Catalent, has developed and manufactured softgel capsules since 1965 and produces more than two billion doses per year. In the past two years, the facility has been subject to seven local and international regulatory inspections with no critical observations, the company reports in a statement.

Source: Catalent