Fixture Display LLC

WARNING LETTER Fixture Display LLC MARCS-CMS 615052 — June 28, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Mr. Alan Gao Fixture Display LLC 2333 Wisconsin Ave Downers Grove , IL 60515 United States cs@fixturedisplays.com Issuing Office: Center for Devices and Radiological Health United States WARNING LETTER June 28, 2021 Re: KN95 Face Mask and 3-ply Surgical Mask Disposable Face Mask Dear Mr. Gao: This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.fixturedisplays.com/ on April 27, 2021. The FDA has observed that your website offers the “KN95 Face Mask” and “3-ply Surgical Mask Disposable Face Mask” for sale in the United States. Based on our review, these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body, and thus, are devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. § 321(h). FDA’s review of your website revealed the following statements that establish that the KN95 Face Mask and 3-ply Surgical Mask Disposable Face Mask are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body, including but not limited to: • Statement that the KN95 Face Masks “are genuinly [sic] KN95 which meets all FDA requirements for medical and trade use” [https://www.fixturedisplays.com/index.php?_route_=Face_Mask_15181-10PK] • Incorporation of the word “surgical” in the name of the 3-ply Surgical Mask Disposable Face Mask [https://www.fixturedisplays.com/index.php?_route_=Face_Mask_15182-10PK&search=surgical%2520mask] 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. 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). 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). 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. FDA registration of a device establishment or assignment of a registration number does not denote FDA approval of the establishment or the device. Thus, references to a firm’s establishment registration and registration number that create an impression of official FDA approval, clearance, authorization, certification, endorsement or other evaluation of the establishment or the devices are misleading and constitute misbranding. See 21 CFR 807.39. Your website contains a number of false or misleading representations, including but not limited to: • Displaying a “Certification of FDA Registration” issued by “UCL-REGSERVICE INC” (UCL-REGSERVICE Certificate) alongside KN95 Face Mask product information. The UCL-REGSERVICE Certificate “certifies that Dongguan Arun Industrial, Co., Ltd.…has completed the FDA Establishment Registration and Device Listing with the US Food & Drug Administration…” The UCL-REGSERVICE Certificate has the look of an official government document, and incorporates unauthorized use of the FDA logo 2 and an illustration of an eagle with a U.S. flag (or a similar flag) [https://www.fixturedisplays.com/index.php?_route_=Face_Mask_15181-10PK&search=mask] • 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. The Shenzhen Certificate “certifies that Dongguan Weier Medical and Technology Co., Ltd.… has completed the FDA Establishment Registration and Device Listing with the US Food & Drug Administration…” The Shenzhen Certificate has the look of an official government document, and incorporates unauthorized use of the FDA logo and an illustration of an eagle with a U.S. flag (or a similar flag) [https://www.fixturedisplays.com/index.php?_route_=Face_Mask_15182-10PK] • Statement alongside the 3-Ply Surgical Mask Disposable Face Mask that the product is “FDA Approved” [https://www.fixturedisplays.com/index.php?_route_=Face_Mask_15182-10PK&search=surgical%2520mask] • Statement that the KN95 Face Masks “are genuinly [sic] KN95 which meets all FDA requirements for medical and trade use” [https://www.fixturedisplays.com/index.php?_route_=Face_Mask_15181-10PK] 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 based on the representations that Dongguan Arun Industrial, Co., Ltd. is or was registered with FDA and that the firm is or was in possession of a registration number. In addition, FDA has not approved the 3-Ply Surgical Mask Disposable Face Mask, so statements to the contrary are false. 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 based on the representations that Dongguan Weier Medical and Technology Co., Ltd is or was registered with FDA and that the firm is or was in possession of a registration number. 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. Such representations are especially concerning from a public health perspective because consumers rely on information provided by sellers to determine whether to purchase a device and your presentation conveys the misimpression that the products have been reviewed and approved by FDA. We remind you that FDA’s Center for Devices and Radiological Health (CDRH) does not issue device registration certificates to medical device establishments, including to sellers and manufacturers. When an establishment registers and lists its devices, the resulting entry in FDA’s Establishment Registration & Device Listing Database merely denotes that the establishment has provided certain information to FDA. This letter is not meant to be an all-inclusive list of violations that exist in connection with the products or your operations. It is your responsibility to ensure that the products you sell are in compliance with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling and promotional materials to ensure that you do not make representations that misbrand the product(s) in violation of the Act. This letter notifies you of our concerns and provides you with an opportunity to address them. Please notify this office in writing within fifteen (15) business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of any actions your firm has taken. If your firm’s planned actions will occur over time, please include a timetable for implementation of those activities. Your firm’s response should be comprehensive and address all violations included in this letter. If you believe that the products are not in violation of the Act, include your reasoning and any supporting information for our consideration. Your firm’s response should be sent via email to CDRHWarningLetterResponses@fda.hhs.gov or by mail to: Food and Drug Administration Center for Devices and Radiological Health Office of Regulatory Programs Division of Regulatory Programs 2: Establishment Support Regulatory Inspections and Audits Team White Oak Building 66 10903 New Hampshire Ave. Silver Spring, MD 20993 Refer to the Document number CMS Case# 615052 or CTS# CPT2000930 when replying. We remind you that only written communication is considered as official. If you have any questions about the contents of this letter, please contact: Assistant Director, Paola Barnett at 301-796-5462 or Paola.Barnett@fda.hhs.gov. Sincerely, /S/ Donna Engleman, MS, BSN Director Division of Market Intelligence Office of Regulatory Programs Office of Product Evaluation and Quality Center for Devices and Radiological Health Cc: Yabo Zhang Dongguan Arun Industrial, Co., Ltd. (FEI Number: 3016661082) NO.18Xingfeng St, Changlong, Huangjiang Dongguan, CN 523766 US Agent: Simcal UCL-REG SERVICE INC. 3907 Prince Street Suite 6F Flushing, NY 11354 Email: gbstandard@163.com UCL-Reg Service 602 ROCKWOOD ROAD, WILMINGTON New Castle, DE, 19802 Haixia Zhang Dongguan Weier Medical and Technology Co., Ltd. NO.6 Santun District Houjie Town Dongguan, CN 523960 US Agent: Angla Li 4402 Gertrude Dr Fremont, CA 94536 Email: xv393fbhh@sina.cn Mr. Alan Lin Shenzen CCT Testing Technology Co. 6F, Fazhan Building, No.04, Shangwu Road, Shiyan Town Bao'an District, Shenzhen, Guangdong, 518108 China Email: fda@fda-test.com _____________________ 1 The KN95 Face Mask offered for sale on your website appears to be the KN95 N9 manufactured by Dongguan Arun Industrial Co., Ltd., which is listed under Appendix A of the Emergency Use Authorization (EUA) for Imported, Non-NIOSH Approved Respirators Manufactured in China (updated February 18, 2021). The EUA, issued pursuant to section 564 of the Act, 21 U.S.C. 360bbb-3, permits emergency use of Dongguan Arun Industrial Co., Ltd.’s KN95 N9 respirator for use in healthcare settings by healthcare personnel (HCP) pursuant to the Centers for Disease Control’s (CDC) recommendations to prevent HCP exposure to pathogenic biological airborne particulates during respirator shortages resulting from the COVID-19 outbreak. However, this EUA does not authorize the Dongguan Arun Industrial Co., Ltd.’s, KN95 N9 respirator to represent that it meets all FDA requirements for medical use. In addition, printed materials, advertising, and promotion must not represent or suggest that the authorized product is FDA-cleared or approved. 2 The FDA logo is for official use by FDA and not for private use on labeling of FDA-regulated products. See FDA Logo Policy (available at: https://www.fda.gov/about-fda/website-policies/fda-logo-policy ) Content current as of: 07/06/2021 Regulated Product(s) Medical Devices