Another product fails to meet requirements.
RAT TESTS FINED
The Therapeutic Goods Administration (TGA) has issued more fines to a company for failing to provide information that demonstrates the effectiveness and safety of a RAT test sold on shelves.
2San Pty Ltd have been slapped with notices totalling $66,600, according to the TGA.
“The Therapeutic Goods Administration (TGA) has issued five infringement notices totalling $66,600 to 2San Pty Ltd for allegedly failing to provide information to the TGA to demonstrate the ongoing minimum level of sensitivity of two COVID-19 rapid antigen tests (RATs).”
The TGA says the fines were issued after being repeatedly ignored by the organisation.
“2San Pty Ltd has been issued multiple infringement notices for serial non-compliance in not meeting deadlines for providing information to the TGA. Officers of the TGA contacted the company on several occasions over a two month period to remind them of their obligations.”
Tests available in pharmacists and supermarkets are currently being analysed by the Doherty Institute in a post-market review commissioned by the Therapeutic Goods Administration.
This will be the latest product in a growing list of RAT tests fined and/or removed from Australian shelves.
In June, the TGA revealed a number of manufacturers were being investigated for “serial non-compliance”.
One sponsor, Hough Pharma, had already been issued with eight fines totalling $106,560 for allegedly failing to provide information related to the safety and performance of three COVID-19 rapid antigen tests.
Hough Pharma was also alleged to have failed in providing adequate customer support.
TCF Trading Co Pty Ltd was also issued an infringement notice of $13,320 in February for the alleged unlawful importation of COVID-19 rapid antigen tests, which were seized at the border.
The RATs that are no longer available on Australian shelves are:
- CovClear by Medi-Stats.
- NowCheck by Life Bioscience.
- COVIFIND by Safe Interact.
- BD Veritor System for Rapid Detection by Becton, Dickinson.
Hough Pharma and 2San Pty Ltd have been warned with their respective fines.
Self-testing kits for COVID-19 were green lit for Australian use in November last year.
They have quickly become the go-to device replacing lengthy PCR tests for workplaces and businesses.
This story goes to show you the lack of grasp the TGA has on the medical market.
Why are the scrambling to regulate products after they have already been released?
It seems like the TGA are playing ‘catch up’, instead of fulfilling their originally intended goal as a group.
Yet we are reminded constantly to ‘trust the science’.
For more TOTT News:
Facebook — Facebook.com/TOTTNews
YouTube — YouTube.com/TOTTNews
Instagram — Instagram.com/TOTTNews
Twitter — Twitter.com/EthanTOTT
Bitchute — Bitchute.com/TOTTNews
Gab — Gab.com/TOTTNews