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Dubak Electrical Group - 613511 - 03/04/2021
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … is intended to mitigate, prevent, treat, diagnose or cure COVID-19 1 in people, and thus is a device under section …
Bespoke Apothecary LLC - 641573 - 09/28/2022
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … The FDA has observed that your website offers your COVID kit and Post Virus Recovery Herbal Tea products for …
Chronic Lyme Treatments - 607094 - 05/07/2020
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … intended to mitigate, prevent, treat, diagnose, or cure COVID-19 [1] in people. Based on our review, these products …
B4B Corp. - 609521 - 02/18/2021
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … is intended to mitigate, prevent, treat, diagnose, or cure COVID-19 1 in people. Based on our review, this product is an …
Applied Biological Laboratories Inc. - 627062 - 03/24/2022
… Misbranded Product Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … intended to mitigate, prevent, treat, diagnose, or cure COVID-19 1 in people. We also reviewed your social media …
AgroTerra, Ltd. dba Patriot Hemp Company - 606086 - 05/07/2020
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … intended to mitigate, prevent, treat, diagnose, or cure COVID-19 [1] in people. Based on our review, these products …
Ionogen, LLC - 608909 - 07/07/2020
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … is intended to mitigate, prevent, treat, diagnose, or cure COVID-19 [1] in people. Based on our review, this product is …
Predictive Biotech - 608322 - 08/17/2020
… Misbranded Product Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … States to mitigate, prevent, treat, diagnose, and/or cure COVID-19 [1] in people. CoreCyte TM is a human cell, tissue, …
NeuroXPF - 606236 - 03/31/2020
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … intended to mitigate, prevent, treat, diagnose, or cure COVID-19 [1] in people. FDA has determined that these …
North Isle Wellness Center - 607947 - 06/19/2020
… … WARNING LETTER Date: June 19, 2020 RE: Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food … intended to mitigate, prevent, treat, diagnose, or cure COVID-19 [1] in people. Based on our review, these products …
Dr. Paul's Lab - 612964 - 02/16/2021
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … https://drsarahsessentials.com, offers your product “COVID-Aid Tincture” for sale in the United States and that …
1 Party At A Time - 609781 - 09/01/2020
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … is intended to mitigate, prevent, treat, diagnose, or cure COVID-19 [1] in people. Based on our review, this product is …
CBD Gaze - 607299 - 05/26/2020
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … products can mitigate, prevent, treat, diagnose, or cure COVID-19 [2] in people. Based on our review, these claims …
BGP, LLC - 613144 - 05/19/2021
… … WARNING LETTER Date: May 19, 2021 TO: adl@biocence.com … Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food … is intended to mitigate, prevent, treat, diagnose, or cure COVID-19 2 and other conditions in people. The FDA also …
SafaLab, Inc. - 611233 - 02/18/2021
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … is intended to mitigate, prevent, treat, diagnose, or cure COVID-19 1 in people. In addition, your website …
Pharmacy2Home/LandiCom Holding LTD - 615137 - 02/03/2022
… intended to mitigate, prevent, treat, diagnose, or cure COVID-19 1 and a variety of other diseases, such as influenza, … by the virus has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, the Department of Health and …
Sonrisa Family Dental dba www.mycovidtest19.com - 607748 - 06/15/2020
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … the mitigation, prevention, treatment, diagnosis or cure COVID-191 in people, and thus are devices under section …
Westminster International Ltd - 613566 - 03/04/2021
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … are intended to mitigate, prevent, treat, diagnose or cure COVID-19 [1] in people, and thus are devices under section …
Dr. Thomas Polucki Upper Cervical Chiropractic, Inc. - 613803 - 07/28/2021
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … intended to mitigate, prevent, treat, diagnose, or cure COVID-19 1 in people. Based on our review, these products are …
Alternative Health Experts LLC DBA Immunization Alternatives - 605884 - 04/06/2020
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … intended to mitigate, prevent, treat, diagnose, or cure COVID-19 [1] in people. Based on our review, these products …
SuperHealthGuard and Loyal Great International Ltd. - 608633 - 06/26/2020
… is intended to mitigate, prevent, treat, diagnose, or cure COVID-19 1 in people. Based on our review, this product is an … by the virus has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, the Department of Health and …
Life Unlearned, LLC - 607754 - 05/19/2020
… … WARNING LETTER Date: May 19, 2020 CC: regulatory-inquires@amazon.com … Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food … products can mitigate, prevent, treat, diagnose, or cure COVID-19 [2] in people. Based on our review, these claims …
Thermavis - 613564 - 03/04/2021
… … Mark Norman Nightingale Thermavis 19 Heather Park Drive London, HA0 1, GB ENGLAND … Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) Dear Sir, This is to advise you that the United … is intended to mitigate, prevent, treat, diagnose or cure COVID-19 1 in people, and thus are devices under section …
Seanjari Preeti Womb Healing, L.L.C. - 607355 - 05/08/2020
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … is intended to mitigate, prevent, treat, diagnose, or cure COVID-19 [1] in people. Based on our review, this product is …
Empowered Diagnostics LLC - 638164 - 10/06/2022
… device manufacturer and distributor of the CovClear COVID-19 Rapid Antigen Tests and the ImmunoPass COVID-19 Neutralizing Antibody Rapid Tests (hereinafter …