Diagnostics firm has 15 days to respond to violations laid out by regulator
The US Food and Drug Administration (FDA) has admonished the molecular diagnostics company Cepheid for failing to maintain good manufacturing practises at their European R&D site in Solna, Sweden, where the viral diagnostic tool, Xpert Norovirus, is produced.
Back in December 2014, Cepheid received FDA clearance to market Xpert Norovirus and shipped the tests out to customers at the beginning of 2015. The in vitro test forms part of Cepheid’s Xpert point-of-care platform, which includes rapid diagnosis standards for HIV and Ebola, and can detect the pathogen within a blood sample in one hour.
In a letter published last week, the FDA criticised Cepheid for the quality of the Xpert Norovirus product being shipped from their facility in Solna. The regulator, after inspecting the facility in March 2015, cites inadequate manufacturing processes for the poor quality control. Cepheid responded to the points raised in April 2015, but the FDA found the responses to be ‘unsatisfactory’.
The FDA has given the diagnostics company 15 business days to reply to the safety violations and detail the actions they will take.