未向FDA申请或经FDA批准即分销产品，FDA发出警告信。
WARNING LETTER
Zhejiang Xichen Medical Technology Co., Ltd.
MARCS-CMS 612946 — JUNE 04, 2021
DATE: June 4, 2021
Re: “FFP2 NR 5-Layer KN95 Face Mask,” “Medical Face Mask,” and “Sterile Surgical Mask”
Dear Yinlong Dong:
This is to advise you that the United States Food and Drug Administration (FDA) has reviewed your website at the internet address https://www.xichen-med.com/ on March 23, 2021. The FDA has observed that your website offers the “FFP2 NR 5-Layer KN95 Face Mask,” “Medical Face Mask,” and “Sterile Surgical Mask” for sale in the United States. Based on our review, these products 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). We also note that the FFP2 NR 5-Layer KN95 Face Mask is intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-191 in people.
特此通知企业，美国食品和药物管理局(FDA)已于2021年3月23日审查了企业的网站，网址为https://www.xichen-med.com/。FDA注意到企业的网站在美国销售“FFP2 NR 5层KN95口罩”、“医用口罩”和“无菌外科口罩”。根据我们的审查，这些产品旨在用于疾病或其他疾病的诊断，或用于治愈、缓解、治疗或预防疾病，或用于影响身体的结构或任何功能，因此，属于《联邦食品、药物和化妆品法案》(“法案”)第201(h)条，21 U.S.C.§321(h)下的医疗器械。我们还注意到，FFP2 NR 5层KN95口罩旨在用于减轻、预防、治疗、诊断或治愈人类COVID-191。
FDA’s review of your website revealed the following statements that establish that the products 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:
FDA对企业网站的审查显示了以下声明，这些声明确定了产品旨在用于疾病或其他疾病的诊断，或用于治愈、减轻、治疗或预防疾病，或用于影响身体的结构或任何功能，包括但不限于:
• Representing the FFP2 NR 5-Layer KN95 Face Mask as a “COVID-19 Respirator” with “effective antibacterial” properties for use to “prevent…bacteria, droplets and other harmful particles,” “filter germs,” and provide “protection for your family” [https://www.xichen-med.com/mask/ffp2-nr-5-layer-kn95-face-mask.html]
•将FFP2 NR 5层KN95口罩表示为“新冠肺炎口罩”，具有“有效抗菌”功能，用于“防止……细菌、液滴和其他有害颗粒物”、“过滤细菌”，并“为家人提供保护”[https://www.xichen-med.com/mask/ffp2-nr-5-layer-kn95-face-mask.html]
• Representing the Medical Face Mask for use to “prevent infection,” “protect patients and other persons from the transmission of pathogenic microorganisms, body fluids, particulate matter, etc., especially in the event of an epidemic or pandemic,” and provide “protection for your family” as well as offering a “bacterial filtration efficiency [of] > 98%” and “microbial cleanliness [of] <30CFY/g” [https://www.xichen-med.com/mask/disposable-mask.html]
•代表医用口罩，用于“预防感染”、“保护患者和其他人免受病原微生物、体液、颗粒物等的传播，特别是在疫情或大流行的情况下”、“为您的家人提供保护”以及提供“细菌过滤效率>98%”，以及“微生物清洁度<30CFY/g”[https://www.xichen-med.com/mask/disposable-mask.html]
• Representing the Sterile Surgical Mask as a “Medical Surgical Mask” that is “antibacterial” and provides a “BFE above 95%” for use to “prevent the spread of body fluids and body splash content and isolate dust, particle [sic], alcohol, blood, bacteria, and virus invading.” [https://www.xichen-med.com/mask/sterile-surgical-mask.html]
•将无菌外科口罩表示为“医用外科口罩”，该口罩具有“抗菌性”，并提供“95%以上的BFE”，用于“防止体液和身体飞溅物的扩散，并隔离灰尘、微粒、酒精、血液、细菌和病毒入侵”[https://www.xichen-med.com/mask/sterile-surgical-mask.html]
The FFP2 NR 5-Layer KN95 Face Mask, Medical Face Mask, and Sterile Surgical Mask (each of which your website indicates is manufactured by Zhejiang Xichen Medical Technology Co. Ltd) are offered for sale in the United States without marketing approval, clearance, or authorization from the FDA. Accordingly, the products are 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). These products are 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).
FFP2 NR 5层KN95口罩、医用口罩和无菌外科口罩(贵公司网站均标明为浙江西辰医疗科技有限公司生产)在美国销售，未经FDA上市批准、许可或授权。因此，根据该法案第501(f)(1)(B)条，21 U.S.C.§351(f)(1)(B)条，产品被掺假，因为贵公司没有根据该法案第515(a)条，21 U.S.C.§360e(a)条批准的有效上市前批准申请(PMA)，或根据该法案第520(g)条，21 U.S.C.§360j(g)条批准的研究器械豁免申请(IDE)。根据该法案第502(o)条，21 U.S.C.§352(o)，这些产品也被定义为错标产品，因为贵公司没有按照该法案第510(k)条，21 U.S.C.§360(k)的要求，通知该机构其将该器械引入商业分销的意图。
In addition, the FFP2 NR 5-Layer KN95 Face Mask is misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because its 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. 21 CFR 807.39.
此外，FFP2 NR 5层KN95口罩根据《法案》第502(a)条，21 U.S.C.§352(a)条被定义为错标产品，因为其标签虚假或具有误导性。FDA对器械机构的注册或注册编号的分配并不表示FDA对机构或器械的批准。因此，提及公司的设立注册和注册编号，会造成FDA官方批准、许可、授权、认证、背书或其他机构或器械评估的印象，这是误导性的，定义为错标产品。21 CFR 807.39。
Your website contains a number of false or misleading representations, including but not limited to:
企业网站含有大量虚假或误导性陈述，包括但不限于:
• Displaying a “FDA REGISTRATION CERTIFICATE” also referred to as the “kn95-FDA Certificate” issued by “J & F Technology Services LLC” (Certificate) under the “About Us” tab on your website. The Certificate certifies that “Zhejiang Xichen Medical Technology Co., Ltd…has completed the FDA Establishment Registration (as manufacturer, foreign exporter, contract manufacturer) and Device Listing with the US Food & Drug Administration.” The Certificate has the look of an official government document, incorporating unauthorized use of the FDA logo2 and an illustration of an eagle and a U.S. flag (or a similar flag). [https://www.xichen-med.com/our-certificate]
•在企业网站的“关于我们”选项卡下显示“FDA注册证书”，也称为“j&f Technology Services LLC”(证书)颁发的“kn95-FDA证书”。该证书证明“浙江西辰医疗科技有限公司……已在美国食品药品监督管理局完成了FDA设立注册(作为制造商、国外出口商、合同制造商)和器械上市。”该证书具有官方政府文件的外观，包括未经授权使用FDA标志和老鹰和美国国旗(或类似国旗)的插图。[https://www.xichen-med.com/our-certificate]
• Displaying a screenshot titled “kn-95-Registration information is available on the FDA website” of what appears to be Zhejiang Xichen Medical Technology Co., Ltd.’s previous entry in FDA’s Establishment Registration & Device Listing Database. [https://www.xichen-med.com/our-certificate]
•显示标题为“kn-95-注册信息可在FDA网站上获得”的截图，该截图似乎是浙江西辰医疗科技有限公司之前在FDA的机构注册和器械清单数据库中的条目。[https://www.xichen-med.com/our-certificate]
Taken together, display of the Certificate, bearing the FDA logo, and a screenshot from FDA’s Establishment Registration & Device Listing Database positioned near images of and information about the FFP2 NR 5-Layer KN95 Face Mask are misleading because they imply FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the product and/or establishment based on the representations that Zhejiang Xichen Medical Technology Co., Ltd. is or was registered with the FDA and that the firm is or was in possession of a registration number. Although the Certificate appears to be intended to function as a disclaimer, 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 Certificate. We also note that you seem to reference the Certificate or some other certificate on the Sterile Surgical Mask’s webpage [https://www.xichen-med.com/mask/sterilesurgical-mask.html], indicating the product has a “Certificate CE, FDA.” These 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.
总的来说，显示带有FDA标志的证书以及位于FFP2 NR 5层KN95口罩图像和信息附近的FDA机构注册和设备清单数据库的截图具有误导性，因为它们暗示了FDA对产品和/或机构的批准、许可、授权、认证、背书或其他评估，这些评估基于浙江西辰医疗科技有限公司的陈述。贵公司已经或曾经在FDA注册，并且该公司现在或曾经拥有注册编号。虽然证书的作用似乎是免责声明，但这种语言的小字体和整体位置很容易被忽视，并且不会限制或以其他方式减轻使用证书所造成的误导印象。我们还注意到，企业似乎在无菌外科口罩的网页[https://www.xichen-med.com/mask/sterilesurgical-mask.html]上引用了证书或其他证书，表明该产品具有“FDA CE证书”。从公共健康的角度来看，这些陈述尤其令人担忧，因为消费者依赖于卖家提供的信息来决定是否购买器械，而企业的陈述传达了一种错误的印象，即产品已经过FDA审查和批准。
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.
我们提醒企业，FDA的设备和放射卫生中心(CDRH)不向医疗设备机构(包括卖方和制造商)颁发设备注册证书。当一家企业注册并列出其器械时，FDA的企业注册和器械清单数据库中的结果条目仅表示该企业已向FDA提供了某些信息。
There is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID -19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS.3 In addition, on March 13, 2020, the President declared a national emergency in response to COVID-19.4 Therefore, FDA is taking urgent measures to protect consumers from certain products that, without approval, clearance, or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. As described above, you sell a product that is intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19 in people. We request that you take immediate action to cease the sale of any adulterated and misbranded products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.
目前全球爆发了由一种新型冠状病毒引起的呼吸系统疾病，这种冠状病毒被命名为“严重急性呼吸系统综合征冠状病毒2型”(SARS-CoV-2)。这种病毒引起的疾病被命名为“2019冠状病毒病”(COVID -19)。2020年1月31日，美国卫生与公众服务部(HHS)发布了与COVID-19有关的公共卫生紧急状态声明，并动员了HHS的运营部门。此外，在2020年3月13日，总统宣布了针对COVID-19.4的国家紧急状态。因此，FDA正在采取紧急措施，保护消费者免受某些产品的影响，这些产品未经FDA批准、许可或授权，声称可以减轻、预防、治疗、诊断，或治愈人类的COVID-19。如上所述，企业销售旨在用于减轻、预防、治疗、诊断或治愈COVID-19的产品。我们要求企业立即采取行动，停止销售任何用于减轻、预防、治疗、诊断或治愈COVID-19的掺假和假冒产品。
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.
本信函并非包含所有与产品或企业的运营相关的违规行为。企业有责任确保销售的产品符合本法案及其实施条例。我们建议企业检查自己的网站、产品标签以及其他标签和促销说明，以确保企业没有违反《法案》对产品进行错误标识的陈述。
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.
这封信通知企业我们的担忧，并为企业提供一个解决这些问题的机会。请在收到本函之日起十五(15)个工作日内以书面形式通知本办公室，说明贵司为解决所注意到的违规行为所采取的具体措施，并说明贵司计划如何防止此类违规行为或类似违规行为再次发生。包括贵公司所采取的任何行动的文件。如果贵公司计划的行动将随着时间的推移而发生，请包括实施这些活动的时间表。贵公司的回复应该是全面的，并处理这封信中包含的所有违规行为。如果企业认为产品没有违反该法案，请提供理由和任何支持信息，以供我们考虑。
If you are not located in the United States, please note that products that appear to be adulterated or misbranded may be detained or refused admission if they are offered for importation into the United States. We may advise the appropriate regulatory officials in the country from which you operate that FDA considers your products listed above to be adulterated and misbranded products that cannot be legally sold to consumers in the United States.
如果企业不在美国，请注意，如果产品似乎被掺假或贴错了标签，如果它们被提供进口到美国，可能会被扣留或拒绝入境。我们可能会通知贵公司经营所在国的相关监管官员，FDA认为贵公司上述产品为掺假和贴错牌产品，不能合法销售给美国消费者。
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# 612946 or CTS Number CPT2001023 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:
US Agent: Fanny Zhao
J & F Technology Services LLC
2424 Morris Ave 818
Union, New Jersey 07083
Email Address: info@jf-yiliao.com
Contact: Yucai.qiu
XICEN International Gmb
Global Office Center, Beethovenstr. 5
DE-60325 Frankfurt/M,Germany
Email Address: yucai.qiu@xicengroup.com
XICEN International Corporation
245 E. Main Street, Suite 107
Alhambra, California, 91801
_________________________________
1 As explained below, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).
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).
3 Secretary of Health and Human Services, Determination that a Public Health Emergency Exists (originally issued Jan. 31, 2020, and subsequently renewed), available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
4 Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (Mar. 13, 2020), available at https://trumpwhitehouse.archives.gov/presidential-actions/proclamationdeclaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
