The Therapeutic Goods Administration said it has issued eight infringement notices to Hough Pharma Pty Ltd.
The TGA said the fines were issued for “allegedly failing to provide information” to the government agency to “demonstrate the safety and performance of three COVID-19 rapid antigen tests”.
“All sponsors of medical devices approved by the TGA are required under the Therapeutic Goods Act 1989 to provide this evidence to the TGA when requested and within the specified timeframe,” the TGA said in a statement.
“This helps ensure medical devices are safe and perform suitably for their intended purpose.”
The government agency also alleged “a lack of customer support has been reported by consumers and verified by TGA investigations”.
However Hough Pharma’s managing director, Jackson Hough, told the Sydney Morning Herald and The Age the company had consistently provided data to the regulator.
Hough also added that the company rejected allegations of a lack of customer service.
“We operate a 1800 number, in addition to email and SMS response options that are provided from 7am–9 pm, seven days a week,” he said in a statement to the newspapers.
Nine.com.au has contacted Hough Pharma and the TGA for comment.