FDA WARNING_LETTER - Irvin, Inc. - May 07, 2021

The FDA issued a Warning Letter to Ms. Cannon regarding theirvincorp.com, which offered "Irvin KN95 PPE Mask" and "Disposable Face Mask" with claims related to COVID-19 mitigation and prevention. The FDA determined these products are devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act. The products were found to be adulterated under section 501(f)(1)(B) because the firm lacked required marketing approval, clearance, or authorization (PMA or IDE). They were also misbranded under section 502(o) for failing to notify the agency of intent to introduce devices into commercial distribution (510(k)). Furthermore, the Irvin KN95 PPE Masks were misbranded under section 502(a) due to false or misleading labeling. Specific misleading representations included claims like "protects from viruses" and "COVID-19 protection," displaying a misleading "Certificate of FDA Registration" from UCL-REGSERVICE INC, a "Certificate of Conformity" from Shenzhen MONLKA Technology Co., Ltd., and unauthorized use of the FDA logo, all implying official FDA approval or endorsement (21 CFR 807.39). The FDA requires immediate action to cease sales of these adulterated and misbranded products. The firm must provide a written response within 15 business days detailing specific corrective actions, prevention plans, and supporting documentation, including a timetable for implementation if necessary. The letter emphasizes the public health concern arising from misleading information, as consumers rely on accurate data for device purchases.