EMA pulls GMP certificate for U.S. facility

Europe
European Medicines Agency

FDA inspectors have taken any number of actions against drugmakers in Europe, but European regulators generally leave any concerns about U.S. companies for the FDA to address. Not Sweden, which has pulled the manufacturing certificate for Capsugel’s Bend Research over what it called ongoing problems.

According to a European Medicines Agency (EMA) report field Monday, Sweden’s regulator said it decided to pull the authorization because of “Repeated failures to correct deficiencies and to provide requested and reliable information.”

The action was taken following an inspection of the facility in Bend, OR, in February when it noted more than 20 deficiencies, including two it deemed critical and 7 that were classified as major. It said the two critical and one of the major deficiencies concerned data integrity. It also cited problems with validation, hygiene routines and other issues. It said the Capsugel facility had not fixed some problems noted in two previous inspections, one last year and one dating to 2012. Drug delivery specialist Capsugel bought Bend in 2013.

In a statement, Capsugel said that is was working "diligently to address the deficiencies," pointing out that the agency didn't ask it to recall any batches. 

"We have initiated a series of Corrective and Preventive Actions, and have retained recognized third-party consultants to verify that our systems, processes, procedures and batch releases meet GMP standards," the statement said. "We are confident that we can resolve this issue quickly so we can continue to support our customers’ ability to provide patients access to the high-quality drug products they need.”

The EMA said the last valid EU GMP certificate for Bend lapsed in August and that it would be blocked from seeking any new drug approvals until problems are fixed and a new certificate issued. The regulator did say it might make an exceptions if Bend is shipping clinical supplies or a marketed product for which there was a “significant patient risk connected to discontinuation of a treatment and no alternative treatment exists.”

Capsugel bought Bend for an undisclosed amount three years ago to get its spray-dried dispersion (SDD) expertise. Capsugel last summer completed a $25 million expansion at Bend, making it into what it said was the largest SDD facility in North America.

- access the EMA report here 

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