Company that has been hired to deliver more than £ 2.3bn worth of testing to UK has been charged with several violations in America by the FDA
A US company that supplied billions of pounds of COVID-19 tests to the UK has been charged with multiple violations in the US by the Food and Drug Administration (FDA).
In a warning letter to the company, the FDA accused Innova of distributing rapid COVID-19 antigen tests in the United States without approval and of using bogus data that inflates their performance.
Innova has won contracts worth at least £ 2.3 billion for the supply of rapid antigenic tests, also known as ‘lateral flow’ tests, from the UK government – the largest supplier of these devices in the United Kingdom, Signing time‘calculations.
The FDA conducted an inspection of Innova’s facilities in Pasadena, California, between March 15 and April 9 of this year, finding several violations of its regulations.
Notably, the FDA found that the Innova Qualitative Antigen Rapid Test was “distributed in the United States without FDA market approval, clearance, or clearance.”
Therefore, the federal agency ordered Innova to “immediately cease the sale and distribution of these unapproved, unauthorized and unauthorized products for use in mitigation, prevention, treatment, diagnosis, or cure. of COVID-19 ″.
The FDA also claims that the labels used on Innova devices were “false or misleading” because they “do not accurately reflect the performance estimates seen in clinical studies of [the] devices ”. According to the regulator, the labels boasted of clinical performance that “appeared unsubstantiated” – both in terms of data submitted to the FDA and published reports of clinical studies on the Innova test.
“The data reliability and accuracy issues noted here raise significant concerns that the performance of the rapid qualitative SARS-CoV-2 antigen test has not been sufficiently established and that the products distributed by Innova without FDA approval, clearance, or clearance could pose a serious risk to public health, ”says the FDA.
The inspection also found that “methods used in, or facilities or controls used for… manufacturing, packaging, storage or installation do not comply with current requirements of good manufacturing practice”.
For example, the FDA suggests that Innova did not verify certain tests provided by a manufacturer in China, which therefore means that the devices were “shipped to customers with incorrect” instructions for use. ” The FDA notes that Innova implemented new control systems and “completed training staff on new procedures and work instructions” after this error was identified.
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However, despite this, the FDA claims that Innova “has not established” adequate procedures “to implement and document corrective and preventive actions.”
The company has been ordered to quickly resolve these issues. In the meantime, US consumers will be advised “not to purchase or use certain products that do not meet FDA requirements and are misrepresented as safe.”
The FDA has invited Innova to respond to its claims, if it considers any of them to be unwarranted. No statement has yet been made by the company. Signing time contacted Innova for comment.
There has been some controversy in the UK over the labeling of Innova tests. It was reported in January that the Department of Health and Social Affairs (DHSC) was repackaging the Innova lateral flow tests, to remove labels suggesting the devices are only intended for professional use for people with symptoms of COVID. -19. Instead, the government has sought to label them as self-tests which should be used on people without symptoms.
According to the report, the manufacturer insisted that the tests are only intended for qualified laboratory personnel. The rebranding exercise was reportedly designed to gain approval from the UK Medicines and Health Products Regulatory Agency (MHRA) for the most flexible use of the devices as quickly as possible.
The effectiveness of lateral flow testing more generally has also been the subject of controversy. As University of Birmingham biostatistics professor Jon Deeks pointed out, government statistics show that in Liverpool lateral flow testing only detected 50% of positive cases identified by PCR testing ” standard ”(and slower). In addition, 30% of high viral load cases went undetected in rapid tests.
The government has, however, repeatedly championed the effectiveness of lateral flow testing, launching a new campaign in April encouraging people to get tested for COVID-19 twice a week, using rapid devices. In March, he claimed that a new analysis showed that lateral flow tests “have a specificity of at least 99.9% when used for testing in the community.”
“The Innova test has already gone through the rigorous evaluation process of Porton Down in the UK, and we have a robust quality assurance process in place,” said a spokesperson for DHSC. “We have confidence in the lateral flow tests, which help us identify people without symptoms but who could pass the virus on to others – helping to break the chains of transmission. “
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