# FDA WARNING_LETTER - Pairon Solutions LLC - July 14, 2021

Source: https://www.keypedia.com/records/warning_letter/pairon-solutions-llc/bf62dcb2-96f7-4744-a3e6-363003b8140c

> FDA WARNING_LETTER for Pairon Solutions LLC on July 14, 2021. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Pairon Solutions LLC
- Inspection Date: 2021-07-14
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On August 9, 2021, the FDA issued a Warning Letter to Pairon Solutions PPE, following a July 14, 2021, review of their website, https://www.paironsolutionsppe.com/. The FDA determined that the "Arun KN95 Folding Face Mask," "Deming Surgical Mask," and "Pairon 3Ply Face Mask" (Blue, White & Black) are devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. § 321(h), due to their intended use for disease mitigation, prevention, treatment, diagnosis, or cure.

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 premarket approval (PMA) or an investigational device exemption (IDE). They are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), for failure to notify the FDA of intent to introduce devices into commercial distribution as required by section 510(k), 21 U.S.C. § 360(k). Furthermore, the products are misbranded

## Related Officers

- [Division Director](https://www.keypedia.com/people/donna-engleman/c1c84c32-c2b5-40fd-86b1-1ee6f35c062c)
- [Crane Yu](https://www.keypedia.com/people/crane-yu/dbd3a43b-ca93-4d3c-acc3-fe86ff44389d)
- [Yabo Zhang](https://www.keypedia.com/people/yabo-zhang/f414be6d-3077-476a-adc8-0a667cbe4ea8)

Company: https://www.keypedia.com/companies/pairon-solutions-llc/8979444b-5beb-4a5a-b2a8-f259ba003ee0

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