FDA WARNING_LETTER - Fixture Display LLC - April 27, 2021

The FDA issued a Warning Letter to FixtureDisplays.com following an April 27, 2021, review of their website, which offered "KN95 Face Mask" and "3-ply Surgical Mask Disposable Face Mask" for sale. The FDA determined these products are medical devices under section 201(h) of the Act. The 3-ply Surgical Mask Disposable Face Mask was found to be adulterated under section 501(f)(1)(B) of the Act because the firm lacked required premarket approval (PMA) or an investigational device exemption (IDE). It was also misbranded under section 502(o) for failure to submit a 510(k) premarket notification. Furthermore, both the KN95 Face Mask and 3-ply Surgical Mask Disposable Face Mask were misbranded under section 502(a) due to false or misleading labeling. Examples include displaying "Certification of FDA Registration" documents with unauthorized FDA logos, claiming products are "FDA Approved," and stating they meet "all FDA requirements for medical and trade use," which misleadingly imply official FDA endorsement or approval, violating 21 CFR 807.39. The firm is required to respond within fifteen business days, detailing specific corrective actions, prevention plans, and a timetable for implementation to ensure compliance with the Act and its regulations.