Xellia, FDA Modify Consent Decree; Site Can Resume Production by 2017

Xellia Pharmaceuticals and the FDA have agreed on a modified consent decree so Xellia can resume manufacturing at the Bedford, Ohio, site it purchased from Ben Venue Laboratories.

Production of sterile injectable anti-infective treatments should resume by the end of 2017, according to the company. Xellia declined to go into detail on the steps taken to resume manufacturing, but significant investments in upgrading the facility.

The modified consent decree permits the company to restart operations at newer parts of the facility, the company said. It added that it would not seek to resume operations in other parts of the plant.

CEO Carl-Åke Carlsson said the site now has 50 employees, and he expects it to have 220 employees by the end of next year. “Our focus is on recruitment and training of the new organization to drive operations and ensure GMP compliance,” he said.

When production at the site restarts, it should significantly increase the company’s U.S. capacity, Xellia said. Currently, more than 40 percent of the company’s total sales come from the U.S. market. The site also should help “alleviate supply shortages for vital anti-infectives and enable future pipeline expansion.”

The original consent decree between the FDA and Ben Venue prevented manufacturing and distribution from the facility after inspections found quality problems, such as particles in some sterile products. Basic cleaning and maintenance issues also were cited.

The decree was approved in January 2013, and Ben Venue stopped operations at the site in December of that year. Xellia purchased major parts for the site last November to update operations.

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