The company was fined S$10,000 for producing 2.2 million masks without the required licence. | So Good News

SINGAPORE – A court on Tuesday (Nov 1) fined a company S$10,000 for producing more than 2.2 million surgical masks without a manufacturer’s license.

The court heard that Inno Medical failed to apply for a license for a year because of an “oversight”.

A representative of the company pleaded guilty to one charge of manufacturing a Class A medical device without a manufacturer’s license.

The court heard that the company has applied to the Health Sciences Authority (HSA) for a manufacturer’s license for the three-ply surgical masks by the end of May 2021.

When the authorities looked into the company, Inno Medical did not have a manufacturer’s license. They noted that the masks were manufactured since April 2020.

Investigations showed that the masks were being sold on platforms like Shopee. The company sells the masks to businesses and individuals, and advertises that the masks are 98 percent effective at filtering bacteria.

In June 2021, The company’s supply of the masks was seized, and the company was ordered to remove its supply from shelves and online listings.

The order was followed by Inno Medical. The application for the manufacturer’s license was reviewed and the premises of the company were inspected. They are found to be clean and well-maintained, and workers are required to don personal protective equipment before entering the production area.

Further investigation seems to suggest that the failure to apply for a license was careless oversight on the company’s part.

The license was granted to the company in July 2021.

Between June 2020 and June 2021, the company produced and sold more than 2.2 million triple-ply surgical masks without a manufacturer’s license.

The HSA prosecutor asked for a fine of S$10,000, saying the company had been manufacturing the masks without a license for 12 months.

In reduction, A representative of the company said that the company incurred a loss because the sales of masks did not generate as much profit as expected.

He said the masks were sold at low prices and the profits did not cover the costs. The price of the masks has gone up from S$20 to a few dollars over time, he said, adding that the cost of importing the materials remains high.

He and a former shareholder of the company said they must pay the fine and support their families. The court considered their circumstances and asked for a reduced fine.

Judge said it was a business decision for them to enter the manufacturing face mask business, possibly because they saw the demand was there.

However, she said that since masks are healthcare products, the company must ensure compliance with relevant regulations and obtain relevant licenses before operating.