Following an inspection that uncovered GMP deficiencies, the Danish Medicines Agency said this week that it has revoked Danish pharmaceutical company Scanpharm A/S’s authorization to manufacture medicinal products and intermediate products. A three-day inspection in September showed the company lacked the necessary knowledge regarding its responsibilities related to qualified persons, as well as other issues with reporting of out-of-specification (OOS) results, OOS and missing data for stability studies and inconsistencies between registration files and specifications. The Danish Medicines Agency also found the company used non-validated analytical methods and did not perform its self-inspection sufficiently. Learn More