The Danish Medicines Agency took action against a violative drugmaker by suspending its authorization to manufacture drugs and intermediates, following an inspection that revealed serious GMP violations.
The agency’s inspection of Scanpharm’s Birkerød facility near Copenhagen revealed inadequate staff training, inconsistent out-of-specification reporting and incomplete stability studies. The DMA also flagged the facility for inadequate self-inspections and for failing to validate its analytical methods.
Scanpharm is marked as “suspended” in the EU’s GMP inspection database, EudraGMDP. It is also barred from contract manufacturing for other pharmaceutical companies.
The agency said the suspension will continue until the company complies with GMP regulations.