INNOVA
2/. The 🇺🇸 FDA goes on specifying one breach after another, including misbranding
This is just page 1
@deeksj @I_M_Stratton
2/. The 🇺🇸 FDA goes on specifying one breach after another, including misbranding
This is just page 1
@deeksj @I_M_Stratton
INNOVA
3/ It gets worse. “The clinical performance estimates reported in the labelling of the ...devices are false and misleading as they do not accurately reflect the performance estimates observed during the clinical studies of your devices.
4/. Quality assurance poor.
3/ It gets worse. “The clinical performance estimates reported in the labelling of the ...devices are false and misleading as they do not accurately reflect the performance estimates observed during the clinical studies of your devices.
4/. Quality assurance poor.
Poor record keeping
Poor acceptance testing
Poor complaints procedure
On and on and on.
So 🇬🇧 Gov spends £billions on Innova Tests and deploys them in ways unsuited to purpose by the 🇺🇸 FDA standards.
Poor acceptance testing
Poor complaints procedure
On and on and on.
So 🇬🇧 Gov spends £billions on Innova Tests and deploys them in ways unsuited to purpose by the 🇺🇸 FDA standards.
Not sure what happened to my tweet one.
But here is the 🇺🇸 FDA issuing a comprehensive warning and cease and desist letter to Innova for selling unapproved lateral flow test devices
It is comprehensive in the scoping of the wrongdoing
fda.gov/inspections-co…
But here is the 🇺🇸 FDA issuing a comprehensive warning and cease and desist letter to Innova for selling unapproved lateral flow test devices
It is comprehensive in the scoping of the wrongdoing
fda.gov/inspections-co…
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