In rapid turnaround, regulators again pull EuropharmaDK’s manufacturing authorization

EU flag depature
EU regulators for a second time in less than a year pulled a GMP certificate from EuropharmaDK, saying it had reverted to the kinds of poor manufacturing practices that initially led them to revoke its authorization.

A Danish medicines repackager has again had its manufacturing certificate yanked by regulators just months after it assured customers that it had resolved its problems to the satisfaction of the Danish Medicines Agency.

According to a report on the EU’s inspection tracking website, a September inspection of EuropharmaDK found the company had fallen back into bad habits, leading EU regulators to once again pull its authorization to sell meds throughout Europe.

“A general lack of will and ability to adhere to the principles of good manufacturing and good distribution practices” was cited as the reason.

Inspectors pointed to the fact that the company’s quality assurance department was not adequately following the corrective and preventive action plan set out last year and confirmed during a reinspection in March. It said complaints and deviations were not being addressed satisfactorily, and the firm didn’t have controls in place to prevent falsification of data about temperature excursions during shipping.

The agency decided against having the company recall all of the products it has shipped, but again quarantined products the company had on hand.

The backsliding came after Europharma earlier this year assured customers that the regulators had lifted a suspension of its manufacturing certificate because the March reinspection satisfied them that many of its problems had been resolved and the company was on the right track.

It said it had hired a new managing director, brought in consultants and “undergone a cultural change, establishing a basis to rebuild trust in the company.”