The Therapeutic Goods Administration said it has issued eight infringement notices to Hough Pharma Pty Ltd.
The TGA said the fines were issued for “alleged failure to provide information” to the government body to “demonstrate the safety and performance of three COVID-19 rapid antigen tests”.
“All sponsors of medical devices approved by the TGA are required by the Therapeutic Goods Act 1989 to provide this evidence to the TGA when requested and within the specified time frame,” the TGA said in a statement.
“This helps ensure that medical devices are safe and function appropriately for their intended purpose.”
The government also claimed that “lack of customer support has been reported by consumers and verified by TGA surveys”.
However, Hough told Pharma’s CEO, Jackson Hough Sydney Morning Herald and Aging the company had consistently provided data to the regulator.
Hough also added that the company denied allegations of lack of customer service.
“We operate a 1800 number, in addition to email and SMS response options, offered from 7 a.m. to 9 p.m., seven days a week,” he said in a statement to the newspapers.
Nine.com.au has contacted Hough Pharma and TGA for comments.