Medical Devices · Jun 28, 2021

Fixture Display LLC

12 extracted findings · 2 model-assigned issue types

FDA source excerpt, selected passage

The 3-ply Surgical Mask Disposable Face Mask (which your website represents is manufactured by Dongguan Weier Medical and Technology Co., Ltd.) is offered for sale in the United States without marketing approval, clearance, or authorization from the FDA.

Labeling, claims & marketing Registration, listing & premarket

FDA published a close-out letter on Oct 4, 2021. The findings below are from the original warning letter.

Findings and supporting evidence

Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.

Registration, listing & premarket

The 3-ply surgical mask was sold without FDA marketing approval, clearance, or authorization.

Supporting FDA text

Source excerpt · automated text-match check
The 3-ply Surgical Mask Disposable Face Mask (which your website represents is manufactured by Dongguan Weier Medical and Technology Co., Ltd.) is offered for sale in the United States without marketing approval, clearance, or authorization from the FDA.

Registration, listing & premarket

The surgical mask lacked an approved PMA or IDE, making it adulterated.

Supporting FDA text

Source excerpt · automated text-match check
Accordingly, this 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).

Registration, listing & premarket

The firm failed to submit a 510(k) notice before introducing the surgical mask.

Supporting FDA text

Source excerpt · automated text-match check
This 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).

Labeling, claims & marketing21 CFR 807.39

Both masks were misbranded because their labeling was false or misleading.

Supporting FDA text

Source excerpt · automated text-match check
In addition, the KN95 Face Mask*1* and the 3-Ply Surgical Mask Disposable Face Mask are misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because their labeling is false or misleading.

Labeling, claims & marketing

The website displayed a misleading FDA registration certificate for the KN95 mask.

Supporting FDA text

Source excerpt · automated text-match check
Displaying a “Certification of FDA Registration” issued by “UCL-REGSERVICE INC” (UCL-REGSERVICE Certificate) alongside KN95 Face Mask product information.

Labeling, claims & marketing

The website displayed a misleading FDA registration certificate for the surgical mask.

Supporting FDA text

Source excerpt · automated text-match check
Displaying a “Certification of FDA Registration” issued by “Shenzhen CCT Testing Technology Co” (Shenzhen Certificate) alongside the 3-ply Surgical Mask Disposable Face Mask product information.

Labeling, claims & marketing

The website falsely claimed the surgical mask was FDA approved.

Supporting FDA text

Source excerpt · automated text-match check
Statement alongside the 3-Ply Surgical Mask Disposable Face Mask that the product is “FDA Approved”

Labeling, claims & marketing

The website falsely claimed the KN95 masks meet all FDA requirements for medical use.

Supporting FDA text

Source excerpt · automated text-match check
Statement that the KN95 Face Masks “are genuinly [sic] KN95 which meets all FDA requirements for medical and trade use”

Labeling, claims & marketing

The FDA logo on the certificate misleadingly implied FDA approval of the KN95 mask.

Supporting FDA text

Source excerpt · automated text-match check
The UCL-REGSERVICE Certificate bearing the FDA logo, positioned near images of and information about the KN95 Face Mask is misleading because it implies FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the product and/or establishment

Labeling, claims & marketing

FDA has not approved the surgical mask, making contrary statements false.

Supporting FDA text

Source excerpt · automated text-match check
In addition, FDA has not approved the 3-Ply Surgical Mask Disposable Face Mask, so statements to the contrary are false.

Labeling, claims & marketing

The FDA logo on the certificate misleadingly implied FDA approval of the surgical mask.

Supporting FDA text

Source excerpt · automated text-match check
Furthermore, display of the Shenzhen Certificate bearing the FDA logo positioned near images of and information about the 3-ply Surgical Mask Disposable Face Mask is misleading because it implies FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the product(s) and/or establishment

Labeling, claims & marketing

Disclaimers on the certificates were too small and placed to mitigate the misleading impression.

Supporting FDA text

Source excerpt · automated text-match check
Although the KN95 Face Mask and 3-ply Surgical Mask Disposable Face Mask Certificates contain legible language that appears to be intended to function as a disclaimer, including a statement that the Certificates do not denote FDA endorsement or approval, statements that FDA does not issue or recognize certificates of registration, and a statement that quotes 21 CFR 807.39, the small font size and overall placement of such language could be easily overlooked and does not limit or otherwise mitigate the misleading impression created by the use of the Certificates.