ALK hit by French injunction after contamination discovered

The French National Agency for Medicines and Health Products Safety has issued an injunction against Danish allergy immunotherapy specialist ALK-Abello, demanding that improvements be made at its manufacturing facility in Vandeuil, France.

This follows the identification of an environmental contamination in the facility’s sterile production area where injectable SCIT products and skin prick tests for the French market are manufactured. ALK has temporarily stopped production in the sterile area and halted the release of all products manufactured there. It has also initiated a recall of all injectable SCIT products released from the affected area since March 2017, and is investing in improvements in manufacturing quality systems across its sites.