WARNING LETTER
Fixture Display LLC
MARCS-CMS 615052 —
June 28, 2021
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
_____________________
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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