The Therapeutic Goods Administration said it issued eight notices of violation to Hough Pharma Pty Ltd.
The TGA said the tickets were issued for “allegedly failing to provide information” to the government agency to “demonstrate the safety and performance of three rapid COVID-19 antigen tests.”
“All sponsors of TGA-approved medical devices are required under the Therapeutic Goods Act of 1989 to provide this evidence to the TGA upon request and within the specified time frame,” the TGA said in a statement.
“This helps ensure that medical devices are safe and function properly for their intended purpose.”
The government agency also alleged that “consumers reported a lack of customer service and TGA investigations verified this.”
However, Hough Pharma managing director Jackson Hough told the Sydney Morning Herald Y Age the company had always provided data to the regulator.
Hough also added that the company has denied accusations of lack of customer service.
“We operate an 1800 number, in addition to email and SMS response options that are provided from 7 am to 9 pm, seven days a week,” he said in a statement to newspapers.
Nine.com.au has contacted Hough Pharma and the TGA for comment.