A Covid-19 rapid antigen test supplier has been fined $106,560 over “serial” failures to comply with the Therapeutic Goods Administration’s guidelines.
Hough Pharma Pty Ltd has been hit with eight infringement notices for allegedly “failing to provide information” to the TGA to demonstrate the safety and performance of three RATs.
The tests, supplied to Coles and Woolworths, allegedly did not provide up-to-date safety and efficacy data nor adequate customer support.
Providers of medical devices approved by the TGA must provide evidence to the agency when requested and within the specified time frame, to ensure the instruments are safe and perform up to standard.
In addition, RAT providers must ensure they have telephone or online operators available for customer support.
In a statement, the TGA said Hough Pharma Pty Ltd had failed to comply.
“Hough Pharma Pty Ltd has been issued multiple infringement notices for serial non compliance,” the statement said.
“In addition to not meeting deadlines for providing information to the TGA, the lack of customer support has been reported by consumers and verified by TGA investigations.
“The TGA is investigating other sponsors of Covid-19 rapid antigen tests for similar noncompliance.”
Hough Pharma’s managing director, Jackson Hough, told Nine Newspapers the company had consistently provided data to the TGA.
“Hough Pharma has continually provided efficacy, safety and variant data to the TGA to demonstrate our products effectively detect Covid-19 and its variants,” he said.