EU regulators come down on repackager they say faked data

EMA
European regulators have pulled the authorization of a Danish pharma repackager they say was faking expiration dates.

European regulators have come down on a Danish pharma repackager that they say tried to hide violations from inspectors.

According to a report on the European Medicines website, the Danish Medicines Agency partially suspended the manufacturing authority of EuroPharma after finding serious breaches of compliance with GMP during an inspection in December.

Inspectors said among other problems EuroPharma falsified the expiration dates on products and sold products from contractors whose sites had never been audited for compliance.

The regulator has already recalled those products it considers affected by a quality defect, like false labeling. It has pulled the company’s manufacturing authorization, saying it will not be allowed to buy or repackage products from EU markets until it can be verified the company it meeting cGMP regulations.

After about 9 months in which the European Medicines Agency was very busy classifying pharma plant inspections, activity appears to have slowed following the Brexit vote by the U,K. to leave the European Union. The EMA is headquartered in London but with the U.K. stepping away from the EU, it is expected to be moved to another country, many of which are anxious to have it. Denmark, is among many that are lobbying to get the prestigious EU agency.