[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-world-packaging-solutions-llc-612824-06282021":3,"fda-latest-sync-dates":30},{"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":13,"case_status":14,"letter_url":15,"reference_number":8,"marcs_cms_no":16,"product_type":17,"delivery_method":8,"recipient_name":18,"recipient_title":8,"body_html":19,"body_text":20,"body_fetched_at":21,"medical_device_id":8,"raw":22,"created_at":28,"updated_at":29},3281,"world-packaging-solutions-llc-612824-06282021","Warning Letter","World Packaging Solutions, LLC",null,"Center for Devices and Radiological Health","Investigational Device Exemptions (IDE)\u002FPremarket Approval Application (PMA) Adulterated Device","2021-07-06","2021-06-28","2021-10-07","Closed Out","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fworld-packaging-solutions-llc-612824-06282021","612824","Medical Devices","Jim Sonsalla","\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>\n  \u003Cdiv class=\"field field--name-field-recipient-name field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Name\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Jim Sonsalla\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                    \n            \u003Cdd>World Packaging Solutions, LLC\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">3901 NW 79th Ave, Suite 245-1468\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Miami\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">FL\u003C\u002Fspan> \u003Cspan class=\"postal-code\">33166\u003C\u002Fspan>\u003Cbr>\n\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:js@wpkgs-ppe.com\"> js@wpkgs-ppe.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: June 28, 2021\u003Cbr>\n\u003Cbr>\nRe: “Purvigor KN95 Mask”\u003C\u002Fp>\n\n\u003Cp>Dear Jim Sonsalla:\u003C\u002Fp>\n\n\u003Cp>This is to advise you that the United States Food and Drug Administration (FDA) has reviewed your website at the Internet address https:\u002F\u002Fwpkgs-ppe.com\u002Fpurvigor-kn95-masks\u002F on May 18, 2021. The FDA has observed that your website offers the “Purvigor KN95 Mask” for sale in the United States. Based on our review, the product is 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).\u003C\u002Fp>\n\n\u003Cp>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:\u003C\u002Fp>\n\n\u003Cp>• Representing that the Purvigor KN95 Mask is intended for use in offering an “anti-infection layer to help protect”, “anti-flu”, “anti-bacterial”, and “PFE [Particle FiltrationEfficiency] ≥ 95% BFE [Bacterial Filtration Efficiency] ≥ 95%” [https:\u002F\u002Fwpkgs-ppe.com\u002Fproduct\u002Fpurvigor-kn95-mask]\u003C\u002Fp>\n\n\u003Cp>The Purvigor KN95 Mask, which your website indicates is manufactured by “Guangdong Fei Fan Mstar Technology Ltd.” (Guangdong), is offered for sale in the United States without marketing approval, clearance, or authorization from the FDA. Accordingly, the 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). The 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).\u003Cbr>\n\u003Cbr>\nIn addition, the Purvigor KN95 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 Guangdong’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.\u003C\u002Fp>\n\n\u003Cp>Your website contains a number of false and\u002For misleading representations, including but not limited to:\u003C\u002Fp>\n\n\u003Cp>• Stating that the Purvigor KN95 Masks are “FDA Registered – NIOSH Tested – CDC Listed.” [https:\u002F\u002Fwpkgs-ppe.com\u002Fpurvigor-kn95-masks\u002F]\u003Cbr>\n• Stating “Approved, FDA EUA Appendix A List” alongside Purvigor KN95 Mask product information. [https:\u002F\u002Fwpkgs-ppe.com\u002Fproduct\u002Fpurvigor-kn95-mask\u002F]\u003Cbr>\n• Displaying the FDA logo\u003Csup>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fsup> on the Purvigor KN95 Mask packaging. [https:\u002F\u002Fwpkgs-ppe.com\u002Fproduct\u002Fpurvigor-kn95-mask\u002F]\u003Cbr>\n• Displaying a “Certification of Registration”, issued by “Shenzhen CTB Testing Technology Co., Ltd” (Shenzhen Certificate) under the “Certification” page on your website. The Shenzhen Certificate “certifies that Guangdong Fei Fan Mstar Technology 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 logo1 and an illustration of an eagle and a U.S. flag (or a similar flag). [https:\u002F\u002Fwpkgs-ppe.com\u002Fcertifications\u002F]\u003Cbr>\n• Displaying a screenshot of what appears to be a previous entry for Guangdong Fei Fan Mstar Technology Ltd in FDA’s Establishment Registration & Device Listing Database. [https:\u002F\u002Fwpkgs-ppe.com\u002Fcertifications\u002F]\u003C\u002Fp>\n\n\u003Cp>Taken together, display of the Shenzhen Certificate, bearing the FDA logo, stating the product is “FDA Registered” and “Approved, FDA EUA Appendix A List,”\u003Csup>\u003Cem>\u003Cstrong>2\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fsup> and displaying a screenshot from FDA’s Establishment Registration & Device Listing Database positioned near images of and information about the Purvigor KN95 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 Guangdong Fei Fan Mstar Technology Ltd is or was registered with FDA and that the firm is or was in possession of a registration number. Although the Shenzhen Certificate for Guangdong contains language that appears to be intended to function as a disclaimer, including a statement that the Certification does 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 the language could be easily overlooked and do not limit or otherwise mitigate the misleading impression created by the use of the Certification. 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 product has 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>This letter is not meant to be an all-inclusive list of violations that exist in connection with the product(s) 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 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 correct 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 product is not in violation of the Act, include your reasoning and any supporting information for our consideration.\u003C\u002Fp>\n\n\u003Cp>Your firm’s response should be sent via email to CDRHWarningLetterResponses@fda.hhs.gov or by mail to:\u003C\u002Fp>\n\n\u003Cp>Food 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\u003Cbr>\n\u003Cbr>\nRefer to the Document number CMS Case Number 612824 or CTS Number CPT2000983 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.\u003C\u002Fp>\n\n\u003Cp>Sincerely,\u003Cbr>\n\u002FS\u002F\u003C\u002Fp>\n\n\u003Cp>Donna Engleman, MS, BSN\u003Cbr>\nDirector Division of Market Intelligence\u003Cbr>\nOffice of Regulatory Programs\u003Cbr>\nOffice of Product Evaluation and Quality\u003Cbr>\nCenter for Devices and Radiological Health\u003Cbr>\n\u003Cbr>\nCc:\u003Cbr>\nShiyuan Wang\u003Cbr>\nGuangdong Fei Fan Mstar Technology Ltd\u003Cbr>\nA1 workshop, No.10, Dongnan Xincun Avenue, Zone 2,\u003Cbr>\nCaobian No.3 Industrial Zone,Dali Town, Nanhai District\u003Cbr>\nFoshan Guangdong, CN 528200\u003C\u002Fp>\n\n\u003Cp>Shenzhen CTB Testing Technology\u003Cbr>\nFirst floor, E building, Huayang\u003Cbr>\nTechnology Industry Park,\u003Cbr>\nGushu Village, Bao'an District,\u003Cbr>\nShenzhen City, P.R.C\u003C\u002Fp>\n\n\u003Cp>_______________________\u003C\u002Fp>\n\n\u003Cp>\u003Cem>\u003Cstrong>1\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: \u003Ca href=\"https:\u002F\u002Fwww.fda.gov\u002Fabout-fda\u002Fwebsite-policies\u002Ffda-logo-policy\">https:\u002F\u002Fwww.fda.gov\u002Fabout-fda\u002Fwebsite-policies\u002Ffda-logo-policy\u003C\u002Fa>)\u003C\u002Fp>\n\n\u003Cp>\u003Cem>\u003Cstrong>2\u003C\u002Fstrong>\u003C\u002Fem> The Purvigor KN95 Face Mask offered for sale on your website appears to be the KN95 model manufactured by Guangdong Fei Fan Mstar Technology Ltd., which was removed from Appendix A of the Emergency Use Authorization (EUA) for Imported, Non-NIOSH Approved Respirators Manufactured in China (updated February 18, 2021) on May 7, 2020. As indicated in the EUA, a respirator model that has been removed from Appendix A is included in a list of respirator models whose authorization has been revoked. The list of removed respirators is maintained on FDA’s EUA webpage (\u003Ca href=\"https:\u002F\u002Fwww.fda.gov\u002Fmedical-devices\u002Fcoronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices\u002Fpersonal-protective-equipment-euas#nolongerauth\">https:\u002F\u002Fwww.fda.gov\u002Fmedical-devices\u002Fcoronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices\u002Fpersonal-protective-equipment-euas#nolongerauth\u003C\u002Fa>).\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\nRecipient Name\n\nJim Sonsalla\n\nWorld Packaging Solutions, LLC\n\n3901 NW 79th Ave, Suite 245-1468\n\nMiami, FL 33166\n\nUnited States\n\njs@wpkgs-ppe.com\n\nIssuing Office:\n\nCenter for Devices and Radiological Health\n\nUnited States\n\nWARNING LETTER\n\nDATE: June 28, 2021\n\nRe: “Purvigor KN95 Mask”\n\nDear Jim Sonsalla:\n\nThis is to advise you that the United States Food and Drug Administration (FDA) has reviewed your website at the Internet address https:\u002F\u002Fwpkgs-ppe.com\u002Fpurvigor-kn95-masks\u002F on May 18, 2021. The FDA has observed that your website offers the “Purvigor KN95 Mask” for sale in the United States. Based on our review, the product is 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).\n\nFDA’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:\n\n• Representing that the Purvigor KN95 Mask is intended for use in offering an “anti-infection layer to help protect”, “anti-flu”, “anti-bacterial”, and “PFE [Particle FiltrationEfficiency] ≥ 95% BFE [Bacterial Filtration Efficiency] ≥ 95%” [https:\u002F\u002Fwpkgs-ppe.com\u002Fproduct\u002Fpurvigor-kn95-mask]\n\nThe Purvigor KN95 Mask, which your website indicates is manufactured by “Guangdong Fei Fan Mstar Technology Ltd.” (Guangdong), is offered for sale in the United States without marketing approval, clearance, or authorization from the FDA. Accordingly, the 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). The 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).\n\nIn addition, the Purvigor KN95 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 Guangdong’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.\n\nYour website contains a number of false and\u002For misleading representations, including but not limited to:\n\n• Stating that the Purvigor KN95 Masks are “FDA Registered – NIOSH Tested – CDC Listed.” [https:\u002F\u002Fwpkgs-ppe.com\u002Fpurvigor-kn95-masks\u002F]\n\n• Stating “Approved, FDA EUA Appendix A List” alongside Purvigor KN95 Mask product information. [https:\u002F\u002Fwpkgs-ppe.com\u002Fproduct\u002Fpurvigor-kn95-mask\u002F]\n\n• Displaying the FDA logo1 on the Purvigor KN95 Mask packaging. [https:\u002F\u002Fwpkgs-ppe.com\u002Fproduct\u002Fpurvigor-kn95-mask\u002F]\n\n• Displaying a “Certification of Registration”, issued by “Shenzhen CTB Testing Technology Co., Ltd” (Shenzhen Certificate) under the “Certification” page on your website. The Shenzhen Certificate “certifies that Guangdong Fei Fan Mstar Technology 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 logo1 and an illustration of an eagle and a U.S. flag (or a similar flag). [https:\u002F\u002Fwpkgs-ppe.com\u002Fcertifications\u002F]\n\n• Displaying a screenshot of what appears to be a previous entry for Guangdong Fei Fan Mstar Technology Ltd in FDA’s Establishment Registration & Device Listing Database. [https:\u002F\u002Fwpkgs-ppe.com\u002Fcertifications\u002F]\n\nTaken together, display of the Shenzhen Certificate, bearing the FDA logo, stating the product is “FDA Registered” and “Approved, FDA EUA Appendix A List,”2 and displaying a screenshot from FDA’s Establishment Registration & Device Listing Database positioned near images of and information about the Purvigor KN95 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 Guangdong Fei Fan Mstar Technology Ltd is or was registered with FDA and that the firm is or was in possession of a registration number. Although the Shenzhen Certificate for Guangdong contains language that appears to be intended to function as a disclaimer, including a statement that the Certification does 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 the language could be easily overlooked and do not limit or otherwise mitigate the misleading impression created by the use of the Certification. 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 product has 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\nThis letter is not meant to be an all-inclusive list of violations that exist in connection with the product(s) 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 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 correct 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 product is not in violation of the Act, include your reasoning and any supporting information for our consideration.\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 Number 612824 or CTS Number CPT2000983 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.\n\nSincerely,\n\n\u002FS\u002F\n\nDonna Engleman, MS, BSN\n\nDirector Division 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\nShiyuan Wang\n\nGuangdong Fei Fan Mstar Technology Ltd\n\nA1 workshop, No.10, Dongnan Xincun Avenue, Zone 2,\n\nCaobian No.3 Industrial Zone,Dali Town, Nanhai District\n\nFoshan Guangdong, CN 528200\n\nShenzhen CTB Testing Technology\n\nFirst floor, E building, Huayang\n\nTechnology Industry Park,\n\nGushu Village, Bao'an District,\n\nShenzhen City, P.R.C\n\n_______________________\n\n1 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\n2 The Purvigor KN95 Face Mask offered for sale on your website appears to be the KN95 model manufactured by Guangdong Fei Fan Mstar Technology Ltd., which was removed from Appendix A of the Emergency Use Authorization (EUA) for Imported, Non-NIOSH Approved Respirators Manufactured in China (updated February 18, 2021) on May 7, 2020. As indicated in the EUA, a respirator model that has been removed from Appendix A is included in a list of respirator models whose authorization has been revoked. The list of removed respirators is maintained on FDA’s EUA webpage (https:\u002F\u002Fwww.fda.gov\u002Fmedical-devices\u002Fcoronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices\u002Fpersonal-protective-equipment-euas#nolongerauth).","2026-08-20T03:00:08.891+00:00",[23,24,25,9,10,26,27,26],"\u003Ctime datetime=\"2021-07-06T13:20:00Z\">07\u002F06\u002F2021\u003C\u002Ftime>\n","\u003Ctime datetime=\"2021-06-28T04:00:00Z\">06\u002F28\u002F2021\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fworld-packaging-solutions-llc-612824-06282021\">World Packaging Solutions, LLC\u003C\u002Fa>","","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fworld-packaging-solutions-llc-612824-09272021\">\u003Ctime datetime=\"2021-10-07T04:00:00Z\">10\u002F07\u002F2021\u003C\u002Ftime>\n\u003C\u002Fa>","2026-08-18T06:42:29.386127+00:00","2026-08-20T03:00:10.981361+00:00",{"510k":31,"classification":32,"enforcement":33,"event":34,"pma":35,"warning_letter":36},"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"]