HSA Uncovers Illegal Surgical Mask Manufacturing and Repackaging Facility, Consumers Advised to Stop Using Masks from Vision Empire Healthcare

The Health Sciences Authority (HSA) uncovered an illegal mask manufacturing and repackaging facility at Ubi Crescent on 31 May 2021. The facility, owned by the company, Vision Empire International Pte Ltd, was suspected to be manufacturing surgical masks without a licence from HSA, a requirement under the Health Products Act.

2     This is the first time a company was suspected to be illegally manufacturing surgical masks in Singapore. The masks were observed to be manufactured in an unhygienic and makeshift environment and placed in carton boxes left out in the open. A total of 33 cartons, each containing about 2,500 masks, were seized.

3     In addition to the illegal manufacturing, the company was also suspected to have imported surgical masks from overseas, repackaged and rebranded with the  company’s packaging before reselling, when they did not have the licence to do so. The masks (both manufactured and repackaged) were sold under the brand ‘Vision Empire Healthcare’.

4     Preliminary investigations revealed that these masks were sold on local e-commerce platforms from $10 to $22 per box of 50. The listings have been removed with the assistance of the platform administrators, and we have directed the company to recall the products from the market. Further investigations are ongoing.

Advisory to consumers

5     Manufacturers and repackers of surgical masks are licensed by HSA to ensure that these masks are manufactured in proper and hygienic conditions that comply with ISO 13485 manufacturing standards so that they are of good quality and safe for use.

6     HSA advises consumers who have purchased masks from the brand ‘Vision Empire Healthcare’ to stop using the masks immediately. Surgical masks from unlicensed facilities have not been verified to meet the appropriate standards of quality, filtration capability and breathability. Sub-standard masks may not provide the desirable level of protection to the wearer. Masks manufactured, repackaged and/or stored under unsanitary conditions may potentially be contaminated or exposed to undesirable impurities from the environment. Wearing such masks may increase the users’ risk of developing skin irritation, respiratory symptoms or infections. Consumers may wish to read the guidelines on masks and view the list of local manufacturers that have been licensed by HSA.

Advisory to manufacturers and suppliers

7     HSA will take strong enforcement action against those who engage in the illegal manufacture and/or supply of masks. Anyone who illegally manufactures and/or supplies such masks is liable to prosecution and if convicted, may be imprisoned for up to 2 years and/or fined up to $50,000.

JUNE 2021

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Consumer, Healthcare professional, Industry member, Medical devices

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