World Packaging Solutions, LLC

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

The Purvigor KN95 Mask, which your website indicates is manufactured by “Guangdong Fei Fan Mstar Technology Ltd.” (Guangdong), is offered for sale in the United States without marketing approval, clearance, or authorization from the FDA. Accordingly, the product is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). The product is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).

Passage 2

In addition, the Purvigor KN95 Mask is misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because its labeling is false or misleading. FDA registration of a device establishment or assignment of a registration number does not denote FDA approval of the establishment or the device. Thus, references to Guangdong’s establishment registration and registration number that create an impression of official FDA approval, clearance, authorization, certification, endorsement or other evaluation of the establishment or the devices are misleading and constitute misbranding. See 21 CFR 807.39.

Passage 3

Your website contains a number of false and/or misleading representations, including but not limited to: • Stating that the Purvigor KN95 Masks are “FDA Registered – NIOSH Tested – CDC Listed.” [https://wpkgs-ppe.com/purvigor-kn95-masks/] • Stating “Approved, FDA EUA Appendix A List” alongside Purvigor KN95 Mask product information. [https://wpkgs-ppe.com/product/purvigor-kn95-mask/] • Displaying the FDA logo***1*** on the Purvigor KN95 Mask packaging. [https://wpkgs-ppe.com/product/purvigor-kn95-mask/] • Displaying a “Certification of Registration”, issued by “Shenzhen CTB Testing Technology Co., Ltd” (Shenzhen Certificate) under the “Certification” page on your website. The Shenzhen Certificate “certifies that Guangdong Fei Fan Mstar Technology Ltd. … has completed the FDA Establishment Registration and Device Listing with the US Food & Drug Administration…” The Shenzhen Certificate has the look of an official government document and incorporates unauthorized use of the FDA logo1 and an illustration of an eagle and a U.S. flag (or a similar flag). [https://wpkgs-ppe.com/certifications/] • Displaying a screenshot of what appears to be a previous entry for Guangdong Fei Fan Mstar Technology Ltd in FDA’s Establishment Registration & Device Listing Database. [https://wpkgs-ppe.com/certifications/]