Pharmaceutical company fined for manufacturing defective medicine
Syri Ltd has been fined 拢51,000 and ordered to pay costs of 拢104,898 by Aylesbury Crown Court.
Today, Syri Ltd, a pharmaceutical manufacturer based in Ruislip, Hillingdon, London has been fined 拢51,000 and ordered to pay costs of 拢104,898 by Aylesbury Crown Court. Following an investigation by the Medicines and Healthcare products Regularly Agency (MHRA) and a prosecution brought by the Crown Prosecution Service (CPS), the company was convicted of바카라 사이트痵upplying a medicinal product which was not of the nature or quality specified in a prescription. The investigation was prompted by a child suffering multiple seizures and their admission to hospital. 바카라 사이트�
The child was prescribed magnesium glycerophosphate to help prevent seizures. However, the medicine made by the company contained just 12% of the strength specified in the prescription, which resulted in it failing to work effectively.바카라 사이트�
The Medicines and Healthcare products Regulatory Agency (MHRA) was alerted to the issue following a report from Milton Keynes University Hospital. MHRA inspectors visited바카라 사이트痶he site and found the methods used to manufacture the medicine and the checks in place to ensure appropriate standards were not met at the time the medicine was supplied. This resulted in the medicine being manufactured with insufficient levels of the active ingredient, making it ineffective and causing the child to become seriously ill.바카라 사이트� 바카라 사이트�
The medicine was made to a specific prescription (known as a special) for the child. The company has improved their quality assurance procedures to prevent a recurrence.바카라 사이트�
Dr Alison Cave, MHRA Chief Safety Officer, said:바카라 사이트�바카라 사이트�
바카라 사이트淧harmaceutical companies such as Syri Ltd have a legal obligation to ensure they produce and supply medicines that work and are manufactured to the required standards.바카라 사이트�바카라 사이트疶he patient has recovered, but the consequences could have been much more serious if it hadn바카라 사이트檛 been for the swift action of hospital staff.바카라 사이트�
바카라 사이트淧atient safety is our top priority.바카라 사이트疶he Agency will not hesitate to take robust enforcement action when serious failings that put patients at risk are identified.바카라 사이트�
Laura Walters, Special Crown Prosecutor of the Crown Prosecution Service said:바카라 사이트�
바카라 사이트淪yri Limited, as with all pharmaceutical providers, have a vital responsibility to produce medicines accurately and safely, in the form specified in a prescription. Fortunately, the mistake they made was not fatal in this case. This was not an isolated mistake although our prosecution was only concerned with this one serious incident.
바카라 사이트淭hese types of prosecutions are thankfully rare, but this conviction and sentence should serve as a reminder for all pharmaceutical companies of the need for absolute care in providing essential medications to the public.바카라 사이트�바카라 사이트� 바카라 사이트�
Anyone who suspects that they, or a member of their family, may have experienced a side effect from a medicine can report it to the MHRA바카라 사이트檚 Yellow Card scheme, which collects and monitors information on suspected safety concerns involving healthcare products.
Notes to Editor바카라 사이트�
- The Medicines and Healthcare products Regulatory Agency is responsible for regulating all medicines and medical devices in the UK. All work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.바카라 사이트�
- The MHRA is an executive agency of the Department of Health and Social Care.