# FDA WARNING_LETTER - World Packaging Solutions, LLC - May 18, 2021

Source: https://www.keypedia.com/records/warning_letter/world-packaging-solutions-llc/9d1a4c13-b423-47e6-99ce-46196c614afb

> FDA WARNING_LETTER for World Packaging Solutions, LLC on May 18, 2021. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: World Packaging Solutions, LLC
- Inspection Date: 2021-05-18
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On June 28, 2021, the FDA issued a Warning Letter to Jim Sonsalla regarding the "Purvigor KN95 Mask" sold on wpkgs-ppe.com. An FDA review on May 18, 2021, found the product is marketed with claims like "anti-infection," "anti-flu," "anti-bacterial," and "PFE ≥ 95% BFE ≥ 95%," classifying it as a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act.

The product is deemed adulterated under section 501(f)(1)(B) because it lacks required marketing approval (PMA or IDE). It is also misbranded under section 502(o) for failure to provide premarket notification (510(k)). Furthermore, the mask is misbranded under section 502(a) due to false or misleading labeling. The website falsely claims "FDA Registered – NIOSH Tested – CDC Listed," "Approved, FDA EUA Appendix A List," and displays the FDA logo, implying official approval. A "Certification of Registration" from Shenzhen CTB Testing Technology Co., Ltd., also misleadingly uses the FDA logo and government imagery. The FDA clarified that establishment registration does not denote product approval and that the Purvigor KN95 Mask was removed from the EUA Appendix A on May 7,

## Related Officers

- [Division Director](https://www.keypedia.com/people/donna-engleman/c1c84c32-c2b5-40fd-86b1-1ee6f35c062c)

Company: https://www.keypedia.com/companies/world-packaging-solutions-llc/56fc4106-8e07-41ba-a3ee-a839fab45992

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