Kikona subsidiary Qisi Intelligence's product has been included in the FDA's Red List and will face the risk of automatic product detention

Kikona subsidiary Qisi Intelligence's product has been included in the FDA's "Red List" and will face the risk of automatic product detention

A product from Kikna's subsidiary Qisi Intelligence has been included in the FDA import alert (red list). Compliance experts have informed two top 2Firsts that once the product is listed on the red list, it will face automatic detention upon export to the United States, without the need for routine inspections.
to update:

 

After this article was published, some experts pointed out that Import Alert 98-06 is only for products rather than companies, that is, this time it is for RAZ DC25000 ENDS products, not all products of Qisi Intelligence.

 

For rigorous considerations, this article has been updated.

 

The official website of the US Food and Drug Administration (FDA) has recently updated its Import Alert 98-06. Two to two Firsts have noticed that a product from Zhuhai Qisi Intelligent Manufacturing Co., Ltd. (hereinafter referred to as "Qisi Intelligent"), a subsidiary of Kekna, has been included in the latest import alert list.

 

According to the FDA website, ZHUHAI QISITECH CO., LTD is included in its updated "Detention Without Physical Examination of New Tobacco Products Without Required Marketing Authorization" on September 26th.

ZHUHAI QISITECH CO., LTD information published on the FDA website | Image source: FDA website

 

Comparing the information released by the FDA and related information from Tianyancha, it was found that ZHUHAI QISITECH CO., LTD, also known as Zhuhai Qisi Intelligent Manufacturing Co., Ltd., was established in 2021 and is a wholly-owned subsidiary of Shenzhen Jikna Technology Co., Ltd. (hereinafter referred to as "Jikna"). Keckner is the brand owner of Geek Bar and Geek Vape, one of the most well-known e-cigarette brands in the United States, and Qisi Intelligence is one of Keckner's main contract manufacturers.

The address of Zhuhai Qisi Intelligent Manufacturing Co., Ltd. is consistent with the address of ZHUHAI QISITECH CO., LTD published on the FDA official website Image source: Tianyancha

Zhuhai Qisi Intelligent Manufacturing Co., Ltd. is a wholly-owned subsidiary of Shenzhen Jikna Technology Co., Ltd. | Source: Tianyancha

According to a search on the FDA official website, departments can detain tobacco products listed on this import warning list without the need for physical inspection (Divisions may detail), without physical examination, the tobacco products identified on the Red List of this Import Alert.), To remove the company's products from the list, information must be provided to the relevant authorities to fully demonstrate that the company has resolved the issues that led to the violation.

 

According to the above provisions, the export of the above-mentioned products from Qisi Intelligence to the United States will be detained until they are removed from the Import Alert 98-06 list.

 

Compliance expert Kurt introduced to two top 2Firsts that Import Alert 98-06 refers to products that have submitted PMTA but have not yet obtained MGO (already obtained STN number), while 98-07 targets products that have not submitted PMTA (not obtained STN number)

 

Two to two Firsts will continue to monitor the progress of the incident and update relevant reports in a timely manner.