[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-workswell-group-sro-613567-03042021":3,"fda-latest-sync-dates":28},{"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":17,"recipient_title":8,"body_html":18,"body_text":19,"body_fetched_at":20,"medical_device_id":8,"raw":21,"created_at":26,"updated_at":27},3479,"workswell-group-sro-613567-03042021","Warning Letter","Workswell Group s.r.o.",null,"Center for Devices and Radiological Health","Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)","2021-03-05","2021-03-04","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fworkswell-group-sro-613567-03042021","613567","Medical Devices","Adam Svestka","\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\">Adam Svestka\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                    \n            \u003Cdd>Workswell Group s.r.o.\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">Libocka 51b\u002F653\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"postal-code\">16100\u003C\u002Fspan> \u003Cspan class=\"locality\">Prague\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">Czechia\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:sales@workswell.cz\"> sales@workswell.cz\u003C\u002Fa>\u003C\u002Fdd>\n    \u003Cdd>\u003Cspan class=\"fa fa-envelope\" aria-hidden=\"true\">\u003C\u002Fspan>\u003Ca href=\"mailto:usa@workswell.eu\"> usa@workswell.eu\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 align=\"center\" class=\"MsoHeader\" style=\"text-align: center;\">\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"tab-stops: center 3.25in right 6.0in;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cb>\u003Cspan style=\"font-family: "Arial",sans-serif;\">WARNING LETTER\u003C\u002Fspan>\u003C\u002Fb>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size: 10.5pt;\">\u003Cspan style=\"tab-stops: .5in 2.5in;\">\u003Cspan style=\"line-height: 11.9pt;\">\u003Cspan style=\"font-family: "Times New Roman",serif;\">\u003Cspan style=\"color: black;\">\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">TO:   \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">Workswell Systems\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">44 Tehama Street\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">San Francisco, CA 94105\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">United States of America\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size: 10.5pt;\">\u003Cspan style=\"line-height: 11.9pt;\">\u003Cspan style=\"font-family: "Times New Roman",serif;\">\u003Cspan style=\"color: black;\">\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">RE:     Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address (https:\u002F\u002Fworkswell-thermal-camera.com\u002F) on February 19, 2021.  We have also reviewed your social media pages at https:\u002F\u002Ftwitter.com\u002Fworkswellcz) and https:\u002F\u002Fwww.facebook.com\u002FWorkswellEU\u002F where you direct consumers to your website, https:\u002F\u002Fworkswell-thermal-camera.com\u002F. The FDA has observed that your website offers a product for measuring human body temperature, specifically the “MEDICAS”, for sale in the United States. Based on our review, this product is intended to mitigate, prevent, treat, diagnose or cure COVID-19\u003Ca href=\"#_ftn1\" name=\"_ftnref1\" style=\"color: blue; text-decoration: underline;\" title=\"\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align: super;\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align: super;\">\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">[1]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fa> in people, and thus is a device under section 201(h) of the Federal, Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. § 321(h).\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">FDA’s review of your website revealed the following statements that establish that the MEDICAS is intended for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, including:\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli>\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"background: white;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">“In conjunction with an increase in skin surface temperature, thermal camera can be used to detect virtually all types of viral (standard flu or for instance SARS-CoV2) or bacterial diseases (common angina) in humans (swine flu, SARS, coronavirus, H5N1, bird flue etc.).” [Published on the MEDICAS webpage, https:\u002F\u002Fworkswell-thermal-camera.com\u002Fthermal-imaging-camera-airport-flue-virus-screening\u002F] \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003Cli>\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"background: white;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">“With a thermal camera, one can easily recognize abnormal temperatures – and diagnose a number of other illnesses, too.” [Published on your “Coronavirus COVID-19” webpage, https:\u002F\u002Fworkswell-thermal-camera.com\u002Fcoronavirus-covid-19-wuhan-virus\u002F] \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003Cli>\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"background: white;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">Your website links to the MEDICAS device webpage and refers to the product as the “Medicas – coronavirus (covid-19) screening camera” and “COVID camera Workswell MEDICAS for fever screening”  [Published on your website, https:\u002F\u002Fworkswell-thermal-camera.com\u002F] \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">The MEDICAS is\u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\"> offered for sale\u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\"> in the United States without marketing approval, clearance, or authorization from FDA.  Accordingly, your 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). Your product is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the product into interstate commerce for commercial distribution as required by section 510(k) of the Act, 21 U.S.C. § 360(k). The introduction or delivery for introduction of these products into interstate commerce is prohibited under section 301(a) of the Act, 21 U.S.C. § 331(a).\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">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>[\u003Ca href=\"#_ftn2\" name=\"_ftnref2\" style=\"color: blue; text-decoration: underline;\" title=\"\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align: super;\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align: super;\">\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">[2]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fa>]\u003C\u002Fsup> In addition, on March 13, 2020, the President declared a national emergency in response to COVID-19\u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\">.\u003Csup>[\u003Ca href=\"#_ftn3\" name=\"_ftnref3\" style=\"color: blue; text-decoration: underline;\" title=\"\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align: super;\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align: super;\">\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">[3]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fa>]\u003C\u002Fsup> \u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\">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 herein, you offer for sale 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 such adulterated and misbranded products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.  \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">Use of telethermographic devices for the assessment of human body temperature can present potentially serious public health risks. Such risks may include, but are not limited to, the device incorrectly detecting a normal human body temperature when a person has an elevated temperature and incorrectly assessing a person to have an elevated body temperature when they do not. A person with an undetected elevated temperature who was subject to temperature assessment using a telethermographic device may, as a result, be less likely to adhere to infection prevention and control guidelines, such as social distancing and using personal protective equipment.  These risks are more likely to be present where telethermographic devices scan multiple individuals simultaneously. Your website, https:\u002F\u002Fworkswell-thermal-camera.com\u002F, includes statements that indicate that the MEDICAS is intended to scan multiple individuals simultaneously, including:\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli style=\"margin-left: 8px;\">\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">“UNLIMITED number of people – all people in field of view are scanned and measured in real-time without delay” [Published on your MEDICAS webpage, https:\u002F\u002Fworkswell-thermal-camera.com\u002Fthermal-imaging-camera-airport-flue-virus-screening\u002F] \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003Cli style=\"margin-left: 8px;\">\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">“[A]ll people are measured in the field of view in real-time” [Published on your MEDICAS webpage, https:\u002F\u002Fworkswell-thermal-camera.com\u002Fthermal-imaging-camera-airport-flue-virus-screening\u002F] \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp class=\"MsoCommentText\">\u003Cspan style=\"font-size: 10pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">\u003Cspan style=\"color: black;\">For more information \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"background: white;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">\u003Cspan style=\"color: rgb(51, 51, 51);\">about FDA’s regulation of\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\"> devices used to mitigate, prevent, treat, diagnose, or cure COVID-19; frequently asked questions; and other helpful resources, \u003Cspan style=\"color: black;\">visit our website at\u003C\u002Fspan> \u003C\u002Fspan>\u003C\u002Fspan>\u003Ca href=\"https:\u002F\u002Fwww.fda.gov\u002Fmedical-devices\u002Femergency-situations-medical-devices\u002Fcoronavirus-covid-19-and-medical-devices\" style=\"color: blue; text-decoration: underline;\">\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">https:\u002F\u002Fwww.fda.gov\u002Fmedical-devices\u002Femergency-situations-medical-devices\u002Fcoronavirus-covid-19-and-medical-devices\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fa>\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">\u003Cspan style=\"color: black;\">. In addition, the guidance titled “Enforcement Policy for Telethermographic Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency”\u003Csup>[\u003C\u002Fsup>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Ca href=\"#_ftn4\" name=\"_ftnref4\" style=\"color: blue; text-decoration: underline;\" title=\"\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align: super;\">\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">\u003Cspan style=\"color: black;\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align: super;\">\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">\u003Cspan style=\"color: black;\">[4]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fa>\u003Csup>\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">\u003Cspan style=\"color: black;\">]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fsup>\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">\u003Cspan style=\"color: black;\"> provides information about FDA’s \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">policies intended to help expand the availability of telethermographic systems used for body temperature measurements for triage use during the COVID-19 public health emergency. \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp class=\"MsoCommentText\">\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">You should take action to address the\u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\"> violations\u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\"> cited in this letter\u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\">. \u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\">This letter is not meant to be an all-inclusive list of violations that exist in connection with your products or 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 websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and\u002For effective for a COVID-19-related use for which they have not been approved, cleared, or authorized by FDA and that you do not make claims that misbrand the products in violation of the Act. \u003Cb>Within 48 hours, please send an email to \u003C\u002Fb>\u003C\u002Fspan>\u003Ca href=\"mailto:COVID-19-Task-Force-CDRH@fda.hhs.gov\" style=\"color: blue; text-decoration: underline;\">\u003Cb>\u003Cspan style=\"font-family: "Arial",sans-serif;\">COVID-19-Task-Force-CDRH@fda.hhs.gov\u003C\u002Fspan>\u003C\u002Fb>\u003C\u002Fa>\u003Cb> \u003C\u002Fb>\u003Cspan style=\"background: white;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">describing the specific steps you have taken to address these\u003C\u002Fspan>\u003C\u002Fspan> \u003Cspan style=\"background: white;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">violations, using CMS # 613567 as reference\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\">. \u003Cspan style=\"background: white;\">Include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation. \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\">Failure to \u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\">adequately \u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\">prevent \u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\">address any\u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\"> violations may result in legal action, including, without limitation, seizure and injunction.\u003C\u002Fspan>  \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp class=\"MsoCommentText\">\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">\u003Cspan style=\"color: black;\">FDA is advising consumers not to purchase or use certain products that have not been approved, cleared, or authorized by FDA and are being misleadingly represented as safe and\u002For effective for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19. Your firm will be added to a published list on FDA's website of firms and websites that have received warning letters from FDA concerning the sale or distribution of COVID-19 related products in violation of the Act. This list can be found at \u003C\u002Fspan>\u003C\u002Fspan>\u003Ca href=\"https:\u002F\u002Fwww.fda.gov\u002Fconsumers\u002Fhealth-fraud-scams\u002Ffraudulent-coronavirus-disease-2019-covid-19-products\" style=\"color: blue; text-decoration: underline;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">https:\u002F\u002Fwww.fda.gov\u002Fconsumers\u002Fhealth-fraud-scams\u002Ffraudulent-coronavirus-disease-2019-covid-19-products\u003C\u002Fspan>\u003C\u002Fa>\u003Cspan style=\"font-family: "Arial",sans-serif;\">\u003Cspan style=\"color: black;\">. \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\">Once you have taken actions to \u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\">address\u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\"> the sale of \u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\">unapproved, uncleared, and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, \u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\">and any appropriate corrective actions have been confirmed by the FDA, the published list will be updated to indicate that your firm has taken \u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\">such\u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\"> corrective \u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\">actions.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp class=\"MsoCommentText\">\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">This letter notifies you of our concerns and provides you with an opportunity to address them. \u003C\u002Fspan>\u003Cspan style=\"background: white;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">If you cannot \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\">take action to address this matter \u003C\u002Fspan>\u003Cspan style=\"background: white;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">completely within 48 hours, state the reason for the delay and the time within which you will do so. If you believe that your product is not in violation of the Act, include your reasoning and any supporting information for our consideration. \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp class=\"MsoCommentText\">\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">If you are not located in the United States, please note that products that appear to be adulterated or misbranded are subject to detention and refusal of 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\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">Please direct any inquiries to FDA at \u003C\u002Fspan>\u003Ca href=\"mailto:COVID-19-Task-Force-CDRH@fda.hhs.gov\" style=\"color: blue; text-decoration: underline;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">COVID-19-Task-Force-CDRH@fda.hhs.gov\u003C\u002Fspan>\u003C\u002Fa>\u003Cspan style=\"font-family: "Arial",sans-serif;\">.  \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp> \u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">Sincerely, \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u002FS\u002F\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">Courtney H. Lias, Ph.D.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">Acting Office Director\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">OHT3: Office of GastroRenal, ObGyn,\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">General Hospital and Urology Devices\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">Office of Product Evaluation and Quality\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">Center for Devices and Radiological Health\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cdiv> \n\u003Chr align=\"left\" size=\"1\" width=\"33%\">\n\u003Cdiv id=\"ftn1\">\n\u003Cp class=\"MsoFootnoteText\">\u003Cspan style=\"font-size: 10pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Csup>\u003Cspan style=\"font-family: "Arial",sans-serif;\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align: super;\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align: super;\">\u003Cspan style=\"font-size: 10pt;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">[1]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fsup>\u003Cspan style=\"font-family: "Arial",sans-serif;\"> As explained below, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\u003C\u002Fdiv>\n\n\u003Cdiv id=\"ftn2\">\n\u003Cp class=\"MsoFootnoteText\">\u003Cspan style=\"font-size: 10pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Csup>\u003Cspan style=\"font-family: "Arial",sans-serif;\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align: super;\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align: super;\">\u003Cspan style=\"font-size: 10pt;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">[2]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fsup>\u003Cspan style=\"font-family: "Arial",sans-serif;\"> Secretary of Health and Human Services Alex M. Azar II, Determination that a Public Health Emergency Exists (originally issued Jan. 31, 2020, and subsequently renewed), \u003Ci>available at\u003C\u002Fi> \u003C\u002Fspan>\u003Ca href=\"https:\u002F\u002Fwww.phe.gov\u002Femergency\u002Fnews\u002Fhealthactions\u002Fphe\u002FPages\u002Fdefault.aspx\" style=\"color: blue; text-decoration: underline;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">https:\u002F\u002Fwww.phe.gov\u002Femergency\u002Fnews\u002Fhealthactions\u002Fphe\u002FPages\u002Fdefault.aspx\u003C\u002Fspan>\u003C\u002Fa>\u003Cspan style=\"font-family: "Arial",sans-serif;\">.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\u003C\u002Fdiv>\n\n\u003Cdiv id=\"ftn3\">\n\u003Cp class=\"MsoFootnoteText\">\u003Cspan style=\"font-size: 10pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Csup>\u003Cspan style=\"font-family: "Arial",sans-serif;\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align: super;\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align: super;\">\u003Cspan style=\"font-size: 10pt;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">[3]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fsup>\u003Cspan style=\"font-family: "Arial",sans-serif;\"> President Donald J. Trump, Proclamation\u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\"> on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19\u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\">) Outbreak (\u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\">Mar. 13, 2020\u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\">), \u003Ci>available at\u003C\u002Fi> \u003C\u002Fspan>\u003Ca href=\"https:\u002F\u002Ftrumpwhitehouse.archives.gov\u002Fpresidential-actions\u002Fproclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak\u002F\" style=\"color: blue; text-decoration: underline;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">https:\u002F\u002Ftrumpwhitehouse.archives.gov\u002Fpresidential-actions\u002Fproclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak\u002F\u003C\u002Fspan>\u003C\u002Fa>\u003Cspan style=\"font-family: "Arial",sans-serif;\">.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\u003C\u002Fdiv>\n\n\u003Cdiv id=\"ftn4\">\n\u003Cp class=\"MsoFootnoteText\">\u003Cspan style=\"font-size: 10pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Csup>\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align: super;\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align: super;\">\u003Cspan style=\"font-size: 10pt;\">\u003Cspan style=\"font-family: "Calibri",sans-serif;\">[4]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fsup> \u003Cspan style=\"font-family: "Arial",sans-serif;\">Accessible\u003Ci> \u003C\u002Fi>at \u003C\u002Fspan>\u003Ca href=\"https:\u002F\u002Fwww.fda.gov\u002Fmedia\u002F137079\u002Fdownload\" style=\"color: blue; text-decoration: underline;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">https:\u002F\u002Fwww.fda.gov\u002Fmedia\u002F137079\u002Fdownload\u003C\u002Fspan>\u003C\u002Fa>\u003Cspan style=\"font-family: "Arial",sans-serif;\">. \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\u003C\u002Fdiv>\n\u003C\u002Fdiv>\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\nAdam Svestka\n\nWorkswell Group s.r.o.\n\nLibocka 51b\u002F653\n\n16100 Prague\n\nCzechia\n\nsales@workswell.cz\n\nusa@workswell.eu\n\nIssuing Office:\n\nCenter for Devices and Radiological Health\n\nUnited States\n\nWARNING LETTER\n\nTO:\n\nWorkswell Systems\n\n44 Tehama Street\n\nSan Francisco, CA 94105\n\nUnited States of America\n\nRE: Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)\n\nThis is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address (https:\u002F\u002Fworkswell-thermal-camera.com\u002F) on February 19, 2021. We have also reviewed your social media pages at https:\u002F\u002Ftwitter.com\u002Fworkswellcz) and https:\u002F\u002Fwww.facebook.com\u002FWorkswellEU\u002F where you direct consumers to your website, https:\u002F\u002Fworkswell-thermal-camera.com\u002F. The FDA has observed that your website offers a product for measuring human body temperature, specifically the “MEDICAS”, for sale in the United States. Based on our review, this product is intended to mitigate, prevent, treat, diagnose or cure COVID-19[1] in people, and thus is a device 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 MEDICAS is intended for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, including:\n\n“In conjunction with an increase in skin surface temperature, thermal camera can be used to detect virtually all types of viral (standard flu or for instance SARS-CoV2) or bacterial diseases (common angina) in humans (swine flu, SARS, coronavirus, H5N1, bird flue etc.).” [Published on the MEDICAS webpage, https:\u002F\u002Fworkswell-thermal-camera.com\u002Fthermal-imaging-camera-airport-flue-virus-screening\u002F]\n\n“With a thermal camera, one can easily recognize abnormal temperatures – and diagnose a number of other illnesses, too.” [Published on your “Coronavirus COVID-19” webpage, https:\u002F\u002Fworkswell-thermal-camera.com\u002Fcoronavirus-covid-19-wuhan-virus\u002F]\n\nYour website links to the MEDICAS device webpage and refers to the product as the “Medicas – coronavirus (covid-19) screening camera” and “COVID camera Workswell MEDICAS for fever screening” [Published on your website, https:\u002F\u002Fworkswell-thermal-camera.com\u002F]\n\nThe MEDICAS is offered for sale in the United States without marketing approval, clearance, or authorization from FDA. Accordingly, your 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). Your product is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the product into interstate commerce for commercial distribution as required by section 510(k) of the Act, 21 U.S.C. § 360(k). The introduction or delivery for introduction of these products into interstate commerce is prohibited under section 301(a) of the Act, 21 U.S.C. § 331(a).\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.[[2]] In addition, on March 13, 2020, the President declared a national emergency in response to COVID-19.[[3]] 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 herein, you offer for sale 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 such adulterated and misbranded products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.\n\nUse of telethermographic devices for the assessment of human body temperature can present potentially serious public health risks. Such risks may include, but are not limited to, the device incorrectly detecting a normal human body temperature when a person has an elevated temperature and incorrectly assessing a person to have an elevated body temperature when they do not. A person with an undetected elevated temperature who was subject to temperature assessment using a telethermographic device may, as a result, be less likely to adhere to infection prevention and control guidelines, such as social distancing and using personal protective equipment. These risks are more likely to be present where telethermographic devices scan multiple individuals simultaneously. Your website, https:\u002F\u002Fworkswell-thermal-camera.com\u002F, includes statements that indicate that the MEDICAS is intended to scan multiple individuals simultaneously, including:\n\n“UNLIMITED number of people – all people in field of view are scanned and measured in real-time without delay” [Published on your MEDICAS webpage, https:\u002F\u002Fworkswell-thermal-camera.com\u002Fthermal-imaging-camera-airport-flue-virus-screening\u002F]\n\n“[A]ll people are measured in the field of view in real-time” [Published on your MEDICAS webpage, https:\u002F\u002Fworkswell-thermal-camera.com\u002Fthermal-imaging-camera-airport-flue-virus-screening\u002F]\n\nFor more information about FDA’s regulation of devices used to mitigate, prevent, treat, diagnose, or cure COVID-19; frequently asked questions; and other helpful resources, visit our website at https:\u002F\u002Fwww.fda.gov\u002Fmedical-devices\u002Femergency-situations-medical-devices\u002Fcoronavirus-covid-19-and-medical-devices. In addition, the guidance titled “Enforcement Policy for Telethermographic Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency”[[4]] provides information about FDA’s policies intended to help expand the availability of telethermographic systems used for body temperature measurements for triage use during the COVID-19 public health emergency.\n\nYou should take action to address the violations cited in this letter. This letter is not meant to be an all-inclusive list of violations that exist in connection with your products or 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 websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and\u002For effective for a COVID-19-related use for which they have not been approved, cleared, or authorized by FDA and that you do not make claims that misbrand the products in violation of the Act. Within 48 hours, please send an email to COVID-19-Task-Force-CDRH@fda.hhs.gov describing the specific steps you have taken to address these violations, using CMS # 613567 as reference. Include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately prevent address any violations may result in legal action, including, without limitation, seizure and injunction.\n\nFDA is advising consumers not to purchase or use certain products that have not been approved, cleared, or authorized by FDA and are being misleadingly represented as safe and\u002For effective for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19. Your firm will be added to a published list on FDA's website of firms and websites that have received warning letters from FDA concerning the sale or distribution of COVID-19 related products in violation of the Act. This list can be found at https:\u002F\u002Fwww.fda.gov\u002Fconsumers\u002Fhealth-fraud-scams\u002Ffraudulent-coronavirus-disease-2019-covid-19-products. Once you have taken actions to address the sale of unapproved, uncleared, and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, and any appropriate corrective actions have been confirmed by the FDA, the published list will be updated to indicate that your firm has taken such corrective actions.\n\nThis letter notifies you of our concerns and provides you with an opportunity to address them. If you cannot take action to address this matter completely within 48 hours, state the reason for the delay and the time within which you will do so. If you believe that your product is 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 are subject to detention and refusal of 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\nPlease direct any inquiries to FDA at COVID-19-Task-Force-CDRH@fda.hhs.gov.\n\nSincerely,\n\n\u002FS\u002F\n\nCourtney H. Lias, Ph.D.\n\nActing Office Director\n\nOHT3: Office of GastroRenal, ObGyn,\n\nGeneral Hospital and Urology Devices\n\nOffice of Product Evaluation and Quality\n\nCenter for Devices and Radiological Health\n\n[1] As explained below, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).\n\n[2] Secretary of Health and Human Services Alex M. Azar II, Determination that a Public Health Emergency Exists (originally issued Jan. 31, 2020, and subsequently renewed), available at https:\u002F\u002Fwww.phe.gov\u002Femergency\u002Fnews\u002Fhealthactions\u002Fphe\u002FPages\u002Fdefault.aspx.\n\n[3] President Donald J. Trump, Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (Mar. 13, 2020), available at https:\u002F\u002Ftrumpwhitehouse.archives.gov\u002Fpresidential-actions\u002Fproclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak\u002F.\n\n[4] Accessible at https:\u002F\u002Fwww.fda.gov\u002Fmedia\u002F137079\u002Fdownload.","2026-08-20T03:18:37.217+00:00",[22,23,24,9,10,25,25,25],"\u003Ctime datetime=\"2021-03-05T17:30:00Z\">03\u002F05\u002F2021\u003C\u002Ftime>\n","\u003Ctime datetime=\"2021-03-04T05:00:00Z\">03\u002F04\u002F2021\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fworkswell-group-sro-613567-03042021\">Workswell Group s.r.o.\u003C\u002Fa>","","2026-08-18T06:42:29.386127+00:00","2026-08-20T03:18:39.355318+00:00",{"510k":29,"classification":30,"enforcement":31,"event":32,"pma":33,"warning_letter":34},"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"]