EuroPharma has received a GMP non-compliance statement from the Danish Medicines Agency.
According to the statement, an inspection at the firm’s plant in Denmark revealed significant GMP violations. The firm deliberately hid information and falsified the expiry date on medicinal products.
The DMA has already recalled several medicinal products that the agency consider affected by incorrect labeling.
As a result of the inspection EuroPharma can no longer perform manufacturing activities including purchasing of medicinal products from other EU markets with the purpose of re-packaging.
Medicinal products that are re-packed may, however, be stored under quarantine, and EuroPharma may still have activities in relation to handling of complaints and recall of batches. The manufacturing authorization is suspended until EuroPharma again complies with GMP which shall be verified during an inspection.
Come this Fall, FDA inspectors will start knocking on your door to assess your compliance with the regulations which means you have a short amount of time to understand and comply with the rules. Stay up-to-date with this FDAnews webinar CD — The New FSMA Rules: Key GMP and Compliance Issues.