MHRA Orders Indian Manufacturer to Recall Batches of Progesterone

British authorities are ordering an Indian manufacturer to recall batches of progesterone injections after an inspection turned up one critical GMP violation and three major ones at one of its facilities.

The UK’s Medicines and Healthcare products Regulatory Agency also is holding off on granting marketing authorization for Akums Drugs and Pharmaceuticals’ manufacturing site in Uttarakhand based on the results of the April 13 inspection.

MHRA’s foremost complaint was that the facility lacked sterility assurance, citing insufficient evidence that all the injection vials had been properly sterilized, a meager sterility sampling plan, and a lack of qualification for the leak test cycle.