ITH Pharma Ltd, based at Premier Park, in London has been charged with seven counts of supplying a medicinal product which was not of the nature or quality specified in the prescription on 27 May 2014.
It has also been charged with failing to take all reasonably practicable steps to ensure that patients were not infected by contaminants, in breach of the Health and Safety at Work Act, between 1 August 2009 and 1 June 2014.
The company is due to appear at Westminster Magistrates’ Court on Monday, December 17.
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A spokesman for ITH Pharma said: “As founders of ITH we have every sympathy for all the families affected, regardless of the cause. However, we are disappointed by the decision to charge the company and will vigorously defend this case. It would not be appropriate to comment further at this stage.”
“Since 2008, ITH has manufactured more than 1.4-million components of total parenteral nutrition and is the sole commercial supplier of reactive feeding solutions to the NHS. This product has helped thousands of extremely vulnerable infants survive premature and complex births. ITH imposes rigorous environmental monitoring on its manufacturing process. The company has always had a strong relationship with the MHRA and continues to receive exemplary ratings for quality and safety.”