# FDA WARNING_LETTER - Shenzhen Weifa Technology Co., Ltd - February 02, 2021

Source: https://www.keypedia.com/records/warning_letter/shenzhen-weifa-technology-co-ltd/1ce72947-7c1b-43ce-a1cf-675accd38f9d

> FDA WARNING_LETTER for Shenzhen Weifa Technology Co., Ltd on February 02, 2021. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Shenzhen Weifa Technology Co., Ltd
- Inspection Date: 2021-02-02
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On March 11, 2021, the FDA issued a Warning Letter to Huaquan Yu of Room 403, Building 117, Sungang Village, Baogang Road, Sungang Street, Shenzhen Shi Guangdong Sheng, 518100 China, following a review of their website, www.starkit.com, on February 2, 2021. The letter addresses the sale of "FFP1 3-ply Non-Woven EarLoop Mask" and "N95/FFP2 Respirator" in the United States.

The FDA determined these products are devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the "Act"), 21 U.S.C. § 321(h). The products are deemed adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because the firm lacks marketing approval, clearance, or authorization from FDA, specifically an approved premarket approval (PMA) application or an investigational device exemption (IDE).

Furthermore, the products are misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), as the firm failed to notify the agency

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Company: https://www.keypedia.com/companies/shenzhen-weifa-technology-co-ltd/b82bb603-11df-4155-8525-6afd35b68f02

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7