The Therapeutic Goods Administration said it has made 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 that medical devices are safe and fit for purpose.”
The government agency also claimed that “a lack of customer support has been reported by consumers and verified by TGA investigations”.
However, the director of Hough Pharma, Jackson Hough, told the… Sydney Morning Herald and The age the company had consistently provided data to the regulator.
“Hough Pharma has continued to provide efficacy, safety and variant data to the TGA to demonstrate that our products effectively detect COVID-19 and its variants,” he said. the papers†
Hough also added that the company rejected allegations of lack of customer service.
“We have an 1800 number, in addition to email and SMS reply options that are offered seven days a week from 7 a.m. to 9 p.m.,” he said in a statement to the papers.
Nine.com.au has contacted Hough Pharma and the TGA for comment.