FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Danes Shutter Drug Importer Over Quality Issues

Nov. 13, 2017

Danish drug regulators have moved to shut down a drug importer and repackager due to its inadequate quality control systems, the Danish Medicines Agency said.

The company, EuroPharma DK, demonstrated “a general lack of will and ability to adhere to the principles of good manufacturing and good distribution practices,” the DMA said in a statement of non-compliance.

The company’s quality control operation is understaffed, the agency said. Based on an inspection in September, the DMA said, the company had done a poor job of solving problems identified in previous inspections. EuroPharma DK also fell short in its handling of complaints, in controlling for temperature variations during transportation of medical products it received and in developing procedures for vetting forwarding shippers.

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