[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-bmhshop-612991-04262021":3,"fda-latest-sync-dates":27},{"id":4,"letter_id":5,"action_type":6,"firm_name":7,"fei_number":8,"issuing_office":9,"subject":10,"posted_date":11,"action_taken_date":12,"response_letter_date":8,"closeout_date":8,"case_status":13,"letter_url":14,"reference_number":8,"marcs_cms_no":15,"product_type":16,"delivery_method":8,"recipient_name":8,"recipient_title":8,"body_html":17,"body_text":18,"body_fetched_at":19,"medical_device_id":8,"raw":20,"created_at":25,"updated_at":26},3278,"bmhshop-612991-04262021","Warning Letter","BMHshop",null,"Center for Devices and Radiological Health","Adulterated and Misbranded Products Related to Coronavirus Disease 2019","2021-07-06","2021-04-26","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fbmhshop-612991-04262021","612991","Medical Devices","\n\n                            \n                            \n                            \n                            \n                                              \n  \n \n\n                 \n\n \n\n\u003Cdiv class=\"inset-column\">\n  \u003Cdl class=\"lcds-description-list--grid\">\n\n      \n      \n              \u003Cdt class=\"cell-1_3\">Product:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_3\">Medical Devices                          \n            \n            \n            \n            \n            \n            \n            \n             \n            \n            \n            \n              \n            \n            \n            \u003C\u002Fdd>\n      \n          \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n\n\u003Chr>\n\n\u003Cdiv class=\"row inset-column\">\n  \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n\n        \u003Cdt>Recipient:\u003C\u002Fdt>\n\n                      \u003Cdd>\u003C\u002Fdd>\n                    \n            \u003Cdd>BMHshop\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n            \n            \u003Cdd>\u003C!-- Loop this field. For FDA Office content type. Display the Other contact channel is a dd span with an icon-->\n\n    \u003C\u002Fdd>\u003Cdd>\u003Cspan class=\"fa fa-envelope\" aria-hidden=\"true\">\u003C\u002Fspan>\u003Ca href=\"mailto:vipcustomer@baimaclub.com\"> vipcustomer@baimaclub.com\u003C\u002Fa>\u003C\u002Fdd>\n\n          \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n       \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n          \n          \u003Cdt>Issuing Office:\u003C\u002Fdt>\n        \n         \n          \u003Cdd>Center for Devices and Radiological Health\u003C\u002Fdd>\n        \n         \n          \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n        \n        \n        \n        \n        \n    \u003C\u002Fdl>\n    \u003Cdl class=\"\"> \n      \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>  \n      \n\u003C\u002Fdiv>\n\n \n\n \n\n\u003Chr>\n\n\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>DATE: April 26, 2021\u003C\u002Fp>\n\n\u003Cp>Re: Adulterated and Misbranded Products Related to Coronavirus Disease 2019\u003C\u002Fp>\n\n\u003Cp>This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address www.bmhshop.comon March 29, 2021. The FDA has observed that your website offers the “KN95 Dust Masks Full Face Mask Protection Filtration >95% Safety N95 Mask” (KN95 Dust Mask), “Medical\u002FSurgical mask”\u002F“Disposable Anti-Dust Breathable 3-layered Masks” (Medical Grade\u002FSurgical Mask), and “Kids Mask Disposable Protective Mask Safety Masks Children Prevent Disease Mask” (Disease Prevention Mask for Child) for sale in the United States. Based on our review, these products are intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19\u003Csup>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fsup> in people, and thus, are devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. § 321(h).\u003C\u002Fp>\n\n\u003Cp>FDA’s review of your website revealed the following statements that establish that the KN95 Dust Mask, Medical Grade\u002FSurgical Mask, and Disease Prevention Mask for Child are intended for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, including but not limited to:\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli>Representing the KN95 Dust Mask as “Anti-COVID-19”, “PROTECTIVE MASK TAKE CARE OF YOU AND YOUR FAMILY…COVID-19…”, “…Quarantine Antivirus”, and “Full Face Mask Protection Filtration >95%” [https:\u002F\u002Fwww.bmhshop.com\u002Fproducts-detail.php?ProId=436]\u003C\u002Fli>\n\t\u003Cli>Representing the Medical Grade\u002FSurgical Mask as “Effective prevention of COVID- 19” and “Multiple protection Against virus infection” [https:\u002F\u002Fwww.bmhshop.com\u002Fproducts.php?CateId=17; https:\u002F\u002Fwww.bmhshop.com\u002Fproducts-detail.php?ProId=170]\u003C\u002Fli>\n\t\u003Cli>Representing the Disease Prevention Mask for Child as “…Children Prevent Disease Mask”, “ANTI-VIRUS”, “Anti-COVID-19”, and “BEST FACE MASKS FOR BACTERIA AND VIRUSES” [https:\u002F\u002Fwww.bmhshop.com\u002Fproductsdetail.php?ProId=424]\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>Based on our review, your website is offering for sale in the United States the KN95 Dust Mask, (which your website represents is manufactured by Zhongshan Dongfeng HuangShang Electronic Factory), the Medical\u002FSurgical Mask, (which your website represents is manufactured by Shenzhen Keyu Electronic Material Trading Co., Ltd), and the Disease Prevention Mask for Child (which, although the text is blurry, your website appears to represent is manufactured by Huizhou Shuangzuan Protection Technology Co., Ltd) without marketing approval, clearance, or authorization from the FDA. Accordingly, these 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).\u003C\u002Fp>\n\n\u003Cp>In addition, these products 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. 21 CFR 807.39.\u003C\u002Fp>\n\n\u003Cp>Your website contains a number of false or misleading representations, including but not limited to:\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli>Displaying a “Certification of Registration” issued by “HealReg Service Inc.” (HealReg Service Certificate) alongside KN95 Dust Mask product information. The HealReg Service Certificate “certifies that Zhongshan Dongfeng HuangShang Electronic Factory…has completed the FDA Establishment Registration and Device Listing with the US Food & Drug Administration…” The HealReg Service Certificate has the look of an official government document and incorporates unauthorized use of the FDA logo\u003Csup>\u003Cem>\u003Cstrong>2\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fsup> and an illustration of an eagle and a U.S. flag (or a similar flag).\u003C\u002Fli>\n\t\u003Cli>Displaying a “Certification of Registration” issued by “Shenzhen SHT Testing Technology Co. Ltd.” (Shenzhen Certificate) alongside Medical Grade\u002FSurgical Mask product information. The Shenzhen Certificate “certifies that Shenzhen Keyu Electronic Material Trading Co., Ltd…was registered with US Food & Drug Administration…pursuit [sic] to the Code of Federal Regulations 21 CFR 807…” The Shenzhen Certificate has the look of an official government document and incorporates unauthorized use of the FDA logo2 and an illustration of an eagle and a U.S. flag (or a similar flag).\u003C\u002Fli>\n\t\u003Cli>Displaying a “Certification of Registration” alongside Disease Prevention Mask for Child product information wherein the text, although blurry, appears to represent and certify that “Huizhou Shuangzuan Protection Technology Co., Ltd” (Huizhou Certificate) “has completed the FDA Establishment Registration and Listing with the US Food & Drug…” Although some of the text is illegible, the Huizhou Certificate has the look of an official government document, incorporating unauthorized use of the FDA logo\u003Csup>\u003Cem>\u003Cstrong>2\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fsup> and an illustration of an eagle and a U.S. flag (or a similar flag).\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>Taken together, the HealReg Service Certificate, bearing the FDA logo, positioned near images of and information about the KN95 Dust Mask are misleading because they imply FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the product and\u002For establishment based on the representations that Zhongshan Dongfeng HuangShang Electronic Factory is or was registered with FDA and that the firm is or was in possession of a registration number. In addition, display of the Shenzhen Certificate, bearing the FDA logo, near images of and information about the Medical Grade\u002FSurgical Mask is misleading because such display implies FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the product and\u002For establishment based on the representations that Shenzhen Keyu Electronic Material Trading Co., Ltd is or was registered with FDA and that the firm is or was in possession of a registration number. Further, display of the Huizhou Certificate, bearing the FDA logo, near images of and information about the Disease Prevention Mask for Child is misleading because such display implies FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the product and\u002For establishment based on the representations that Huizhou Shuangzuan Protection Technology Co., Ltd is or was registered with FDA and the firm is or was in possession of a registration number. Although the HealReg Service Certificate and Shenzhen Certificate contain legible language that appears to be intended to function as a disclaimer, including a statement that the Certifications 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 Certifications. 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.\u003C\u002Fp>\n\n\u003Cp>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.\u003C\u002Fp>\n\n\u003Cp>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.\u003Csup>\u003Cem>\u003Cstrong>3\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fsup> In addition, on March 13, 2020, the President declared a national emergency in response to COVID-19.\u003Csup>\u003Cem>\u003Cstrong>4\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fsup> 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 products that are 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.\u003C\u002Fp>\n\n\u003Cp>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 are not misleadingly representing the products as safe and\u002For effective for a COVID-19-related use for which they have not been approved, cleared, authorized by FDA and that you do not make representations that misbrand the products in violation of the Act.\u003C\u002Fp>\n\n\u003Cp>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.\u003C\u002Fp>\n\n\u003Cp>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.\u003C\u002Fp>\n\n\u003Cp>Your firm’s response should be sent via email to CDRHWarningLetterResponses@fda.hhs.gov or by mail to:\u003Cbr>\n\u003Cbr>\nFood and Drug Administration\u003Cbr>\nCenter for Devices and Radiological Health\u003Cbr>\nOffice of Regulatory Programs\u003Cbr>\nDivision of Regulatory Programs 2: Establishment Support\u003Cbr>\nRegulatory Inspections and Audits Team\u003Cbr>\nWhite Oak Building 66\u003Cbr>\n10903 New Hampshire Ave.\u003Cbr>\nSilver Spring, MD 20993\u003C\u002Fp>\n\n\u003Cp>Refer to the Document number CMS Case# 612991 or CTS Number CPT2001079when 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.\u003C\u002Fp>\n\n\u003Cp>Sincerely,\u003Cbr>\n\u002FS\u002F\u003C\u002Fp>\n\n\u003Cp>Donna Engleman, MS, BSN\u003Cbr>\nDirector\u003Cbr>\nDivision of Market Intelligence\u003Cbr>\nOffice of Regulatory Programs\u003Cbr>\nOffice of Product Evaluation and Quality\u003Cbr>\nCenter for Devices and Radiological Health\u003C\u002Fp>\n\n\u003Cp>\u003Cbr>\nCc:\u003Cbr>\nJasmine Qiu\u003Cbr>\nZhongshan Dongfeng HuangShang Electronic Factory\u003Cbr>\n2\u002FF, No.172, South of Dongfeng Avenue, Anle village,\u003Cbr>\nDongfeng Town, Zhongshan City Guangdong, CN 528425\u003C\u002Fp>\n\n\u003Cp>US Agent:\u003Cbr>\nYueting Zhu\u003Cbr>\nSouth Bay Innovation, LLC\u003Cbr>\n2525 Vista Industria\u003Cbr>\nCompton, CA 90221\u003Cbr>\nCtb-lab@outlook.com\u003C\u002Fp>\n\n\u003Cp>Simon Lee\u003Cbr>\nHealReg Service Inc.\u003Cbr>\n13 Barksdale Professional Center, Newark DE 19711\u003Cbr>\nCtb-lab@outlook.com\u003C\u002Fp>\n\n\u003Cp>Huanqing Chen\u003Cbr>\nShenzhen Keyu Electronic Material Trading Co., Ltd.\u003Cbr>\nD25, Floor 3, Building 23, Dayun Software Town, 8288 Longgang Avenue,\u003Cbr>\nYuanshan street, Longgang District, Shenzhen Guangdong, CN 518000\u003C\u002Fp>\n\n\u003Cp>US Agent:\u003Cbr>\nWilson Cheung\u003Cbr>\n704 Bergen St 1fl\u003Cbr>\nHarrison, NJ US 07029\u003Cbr>\nEmail: Wilson.Cheung.FDA@gmail.com\u003C\u002Fp>\n\n\u003Cp>Shenzhen SHT Technology Co. Ltd.\u003Cbr>\nRoom 613, Bozhi Centre, Chentian Industrial Area,\u003Cbr>\nXixiang Street, Baoan District, Shenzhen, China\u003Cbr>\nEmail: 348547703@qq.com\u003C\u002Fp>\n\n\u003Cp>Mr. Lian\u003Cbr>\nHuizhou Shuangzuan Protection Technology Co., Ltd\u003Cbr>\nPlant No. 108, Tangquan Section, Huizhou Avenue\u003Cbr>\nHuicheng District, Huizhou City, China\u003Cbr>\nE-mail: admin@beist88.com\u003C\u002Fp>\n\n\u003Cp>US Agent: Angla Li\u003Cbr>\n4402 Gertrude Dr\u003Cbr>\nFremont, CA US 94536\u003Cbr>\nEmail: xv393fbhh@sina.cn\u003C\u002Fp>\n\n\u003Cp>_________________________\u003C\u002Fp>\n\n\u003Cp>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem> As explained below, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).\u003C\u002Fp>\n\n\u003Cp>\u003Cem>\u003Cstrong>2\u003C\u002Fstrong>\u003C\u002Fem> 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:\u002F\u002Fwww.fda.gov\u002Fabout-fda\u002Fwebsite-policies\u002Ffda-logo-policy).\u003C\u002Fp>\n\n\u003Cp>\u003Cem>\u003Cstrong>3\u003C\u002Fstrong>\u003C\u002Fem> Secretary of Health and Human Services Alex M. Azar II, Determination that a Public Health Emergency Exists. Jan. 31, 2020. (Accessible at https:\u002F\u002Fwww.phe.gov\u002Femergency\u002Fnews\u002Fhealthactions\u002Fphe\u002FPages\u002F2019-nCoV.aspx). The declaration has been renewed for an additional 90 days three times. The most recent renewal went into effect on October 23, 2020. Secretary of Health and Human Services Alex M. Azar II, Renewal of Determination that a Public Health Emergency Exists. October 2, 2020. (Accessible at https:\u002F\u002Fwww.phe.gov\u002Femergency\u002Fnews\u002Fhealthactions\u002Fphe\u002FPages\u002Fcovid19-2Oct2020.aspx).\u003C\u002Fp>\n\n\u003Cp>\u003Cem>\u003Cstrong>4\u003C\u002Fstrong>\u003C\u002Fem> President Donald J. Trump, Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19). Mar. 13, 2020. (Accessible at https:\u002F\u002Fwww.whitehouse.gov\u002Fpresidential-actions\u002Fproclamationdeclaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak\u002F).\u003C\u002Fp>\n\n\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\n\n\n              \n                                            \n              \n            ","Product:\n\nMedical Devices\n\nRecipient:\n\nBMHshop\n\nUnited States\n\nvipcustomer@baimaclub.com\n\nIssuing Office:\n\nCenter for Devices and Radiological Health\n\nUnited States\n\nWARNING LETTER\n\nDATE: April 26, 2021\n\nRe: Adulterated and Misbranded Products Related to Coronavirus Disease 2019\n\nThis is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address www.bmhshop.comon March 29, 2021. The FDA has observed that your website offers the “KN95 Dust Masks Full Face Mask Protection Filtration >95% Safety N95 Mask” (KN95 Dust Mask), “Medical\u002FSurgical mask”\u002F“Disposable Anti-Dust Breathable 3-layered Masks” (Medical Grade\u002FSurgical Mask), and “Kids Mask Disposable Protective Mask Safety Masks Children Prevent Disease Mask” (Disease Prevention Mask for Child) for sale in the United States. Based on our review, these products are intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-191 in people, and thus, are devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. § 321(h).\n\nFDA’s review of your website revealed the following statements that establish that the KN95 Dust Mask, Medical Grade\u002FSurgical Mask, and Disease Prevention Mask for Child are intended for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, including but not limited to:\n\nRepresenting the KN95 Dust Mask as “Anti-COVID-19”, “PROTECTIVE MASK TAKE CARE OF YOU AND YOUR FAMILY…COVID-19…”, “…Quarantine Antivirus”, and “Full Face Mask Protection Filtration >95%” [https:\u002F\u002Fwww.bmhshop.com\u002Fproducts-detail.php?ProId=436]\n\nRepresenting the Medical Grade\u002FSurgical Mask as “Effective prevention of COVID- 19” and “Multiple protection Against virus infection” [https:\u002F\u002Fwww.bmhshop.com\u002Fproducts.php?CateId=17; https:\u002F\u002Fwww.bmhshop.com\u002Fproducts-detail.php?ProId=170]\n\nRepresenting the Disease Prevention Mask for Child as “…Children Prevent Disease Mask”, “ANTI-VIRUS”, “Anti-COVID-19”, and “BEST FACE MASKS FOR BACTERIA AND VIRUSES” [https:\u002F\u002Fwww.bmhshop.com\u002Fproductsdetail.php?ProId=424]\n\nBased on our review, your website is offering for sale in the United States the KN95 Dust Mask, (which your website represents is manufactured by Zhongshan Dongfeng HuangShang Electronic Factory), the Medical\u002FSurgical Mask, (which your website represents is manufactured by Shenzhen Keyu Electronic Material Trading Co., Ltd), and the Disease Prevention Mask for Child (which, although the text is blurry, your website appears to represent is manufactured by Huizhou Shuangzuan Protection Technology Co., Ltd) without marketing approval, clearance, or authorization from the FDA. Accordingly, these 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).\n\nIn addition, these products 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. 21 CFR 807.39.\n\nYour website contains a number of false or misleading representations, including but not limited to:\n\nDisplaying a “Certification of Registration” issued by “HealReg Service Inc.” (HealReg Service Certificate) alongside KN95 Dust Mask product information. The HealReg Service Certificate “certifies that Zhongshan Dongfeng HuangShang Electronic Factory…has completed the FDA Establishment Registration and Device Listing with the US Food & Drug Administration…” The HealReg Service Certificate has the look of an official government document and incorporates unauthorized use of the FDA logo2 and an illustration of an eagle and a U.S. flag (or a similar flag).\n\nDisplaying a “Certification of Registration” issued by “Shenzhen SHT Testing Technology Co. Ltd.” (Shenzhen Certificate) alongside Medical Grade\u002FSurgical Mask product information. The Shenzhen Certificate “certifies that Shenzhen Keyu Electronic Material Trading Co., Ltd…was registered with US Food & Drug Administration…pursuit [sic] to the Code of Federal Regulations 21 CFR 807…” The Shenzhen Certificate has the look of an official government document and incorporates unauthorized use of the FDA logo2 and an illustration of an eagle and a U.S. flag (or a similar flag).\n\nDisplaying a “Certification of Registration” alongside Disease Prevention Mask for Child product information wherein the text, although blurry, appears to represent and certify that “Huizhou Shuangzuan Protection Technology Co., Ltd” (Huizhou Certificate) “has completed the FDA Establishment Registration and Listing with the US Food & Drug…” Although some of the text is illegible, the Huizhou 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).\n\nTaken together, the HealReg Service Certificate, bearing the FDA logo, positioned near images of and information about the KN95 Dust Mask are misleading because they imply FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the product and\u002For establishment based on the representations that Zhongshan Dongfeng HuangShang Electronic Factory is or was registered with FDA and that the firm is or was in possession of a registration number. In addition, display of the Shenzhen Certificate, bearing the FDA logo, near images of and information about the Medical Grade\u002FSurgical Mask is misleading because such display implies FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the product and\u002For establishment based on the representations that Shenzhen Keyu Electronic Material Trading Co., Ltd is or was registered with FDA and that the firm is or was in possession of a registration number. Further, display of the Huizhou Certificate, bearing the FDA logo, near images of and information about the Disease Prevention Mask for Child is misleading because such display implies FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the product and\u002For establishment based on the representations that Huizhou Shuangzuan Protection Technology Co., Ltd is or was registered with FDA and the firm is or was in possession of a registration number. Although the HealReg Service Certificate and Shenzhen Certificate contain legible language that appears to be intended to function as a disclaimer, including a statement that the Certifications 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 Certifications. 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.\n\nWe 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.\n\nThere 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 products that are 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.\n\nThis 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 are not misleadingly representing the products as safe and\u002For effective for a COVID-19-related use for which they have not been approved, cleared, authorized by FDA and that you do not make representations that misbrand the products in violation of the Act.\n\nThis 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.\n\nIf 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.\n\nYour firm’s response should be sent via email to CDRHWarningLetterResponses@fda.hhs.gov or by mail to:\n\nFood and Drug Administration\n\nCenter for Devices and Radiological Health\n\nOffice of Regulatory Programs\n\nDivision of Regulatory Programs 2: Establishment Support\n\nRegulatory Inspections and Audits Team\n\nWhite Oak Building 66\n\n10903 New Hampshire Ave.\n\nSilver Spring, MD 20993\n\nRefer to the Document number CMS Case# 612991 or CTS Number CPT2001079when 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.\n\nSincerely,\n\n\u002FS\u002F\n\nDonna Engleman, MS, BSN\n\nDirector\n\nDivision of Market Intelligence\n\nOffice of Regulatory Programs\n\nOffice of Product Evaluation and Quality\n\nCenter for Devices and Radiological Health\n\nCc:\n\nJasmine Qiu\n\nZhongshan Dongfeng HuangShang Electronic Factory\n\n2\u002FF, No.172, South of Dongfeng Avenue, Anle village,\n\nDongfeng Town, Zhongshan City Guangdong, CN 528425\n\nUS Agent:\n\nYueting Zhu\n\nSouth Bay Innovation, LLC\n\n2525 Vista Industria\n\nCompton, CA 90221\n\nCtb-lab@outlook.com\n\nSimon Lee\n\nHealReg Service Inc.\n\n13 Barksdale Professional Center, Newark DE 19711\n\nCtb-lab@outlook.com\n\nHuanqing Chen\n\nShenzhen Keyu Electronic Material Trading Co., Ltd.\n\nD25, Floor 3, Building 23, Dayun Software Town, 8288 Longgang Avenue,\n\nYuanshan street, Longgang District, Shenzhen Guangdong, CN 518000\n\nUS Agent:\n\nWilson Cheung\n\n704 Bergen St 1fl\n\nHarrison, NJ US 07029\n\nEmail: Wilson.Cheung.FDA@gmail.com\n\nShenzhen SHT Technology Co. Ltd.\n\nRoom 613, Bozhi Centre, Chentian Industrial Area,\n\nXixiang Street, Baoan District, Shenzhen, China\n\nEmail: 348547703@qq.com\n\nMr. Lian\n\nHuizhou Shuangzuan Protection Technology Co., Ltd\n\nPlant No. 108, Tangquan Section, Huizhou Avenue\n\nHuicheng District, Huizhou City, China\n\nE-mail: admin@beist88.com\n\nUS Agent: Angla Li\n\n4402 Gertrude Dr\n\nFremont, CA US 94536\n\nEmail: xv393fbhh@sina.cn\n\n_________________________\n\n1 As explained below, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).\n\n2 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:\u002F\u002Fwww.fda.gov\u002Fabout-fda\u002Fwebsite-policies\u002Ffda-logo-policy).\n\n3 Secretary of Health and Human Services Alex M. Azar II, Determination that a Public Health Emergency Exists. Jan. 31, 2020. (Accessible at https:\u002F\u002Fwww.phe.gov\u002Femergency\u002Fnews\u002Fhealthactions\u002Fphe\u002FPages\u002F2019-nCoV.aspx). The declaration has been renewed for an additional 90 days three times. The most recent renewal went into effect on October 23, 2020. Secretary of Health and Human Services Alex M. Azar II, Renewal of Determination that a Public Health Emergency Exists. October 2, 2020. (Accessible at https:\u002F\u002Fwww.phe.gov\u002Femergency\u002Fnews\u002Fhealthactions\u002Fphe\u002FPages\u002Fcovid19-2Oct2020.aspx).\n\n4 President Donald J. Trump, Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19). Mar. 13, 2020. (Accessible at https:\u002F\u002Fwww.whitehouse.gov\u002Fpresidential-actions\u002Fproclamationdeclaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak\u002F).","2026-08-20T02:59:18.086+00:00",[21,22,23,9,10,24,24,24],"\u003Ctime datetime=\"2021-07-06T13:20:00Z\">07\u002F06\u002F2021\u003C\u002Ftime>\n","\u003Ctime datetime=\"2021-04-26T04:00:00Z\">04\u002F26\u002F2021\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fbmhshop-612991-04262021\">BMHshop\u003C\u002Fa>","","2026-08-18T06:42:29.386127+00:00","2026-08-20T02:59:20.205603+00:00",{"510k":28,"classification":29,"enforcement":30,"event":31,"pma":32,"warning_letter":33},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-20T03:28:02.95+00:00"]