THE Therapeutic Goods Administration (TGA) has issued COVID-19 rapid antigen test sponsor, 2San Pty Ltd, with five infringement notices totalling $66,600.
The company allegedly failed to provide information to the TGA to demonstrate the ongoing minimum level of sensitivity of two RAT products.
"2San Pty Ltd has been issued multiple infringement notices for serial non-compliance in not meeting deadlines for providing information to the TGA," the TGA reported.
"Officers of the TGA contacted the company on several occasions over a two month period to remind them of their obligations.
"This compliance action serves as a reminder to companies to take their obligations seriously.
"Suppliers of products such as COVID-19 tests must meet their ongoing responsibilities with respect to post-market vigilance and monitoring."
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