MHRA Orders Recall Over GMP Deficiencies at Indian Plant
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.
The three major deficiencies were for inadequate control and validation of sterilization, problems across all aspects of the quality management system, and the lack of a robust environmental monitoring program. Additionally, the inspection turned up 13 lesser violations, but declined to formally report them.
Based on these findings, the agency is recalling four batches of Nordic Pharma’s unlicensed progesterone injections supplied to the UK and Ireland.
MHRA expects only a few stocks of the product to remain on the market.
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