The Department is in regular dialogue with the Medicines and Healthcare products Regulatory Agency (MHRA) and they have advised it continues to work closely with the company to ensure that they make the necessary changes. The MHRA Inspectors have made on-site technical visits, carried out further inspections and its senior management has met with the company on a number of occasions to discuss the improvements which need to be implemented. The MHRA has recently advised that progress is being made and it is currently awaiting the results of a third-party audit, carried out on behalf of the company, which will independently assess the measures implemented to date. Once the MHRA has reviewed the outcome of this audit they anticipate carrying out further inspections to confirm that the company has implemented the necessary changes to bring their aseptic procedures into compliance.
In addition to Calea UK Ltd, there are four commercial operations authorised to provide Total Parenteral Nutrition (TPN) to the National Health Service. There are a number (approximately 40) of NHS units also authorised by the MHRA for manufacture and supply of TPNs across the NHS.