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21st Century LaserMed Pain Institute d/b/a Create Wellness Clinics - 607654 - 07/21/2020
… Adulterated 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. There is currently a global outbreak of …
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, …
Lattice Biologics, Ltd. - 607852 - 08/27/2020
… Syndrome (ARDS) related to Coronavirus Disease 2019 (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 …
North Coast Biologics - 607532 - 05/21/2020
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … vaccine.” The FDA has observed that you have offered this COVID-19 vaccine product for sale in the United States and …
Vibrant Health Care, Inc. - 608426 - 11/18/2020
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … States to mitigate, prevent, treat, diagnose, or cure COVID-19 [1] in people. Your product is a human cell, tissue, …
Konrad Rejdak, M.D., Ph.D. - 671405 - 05/29/2024
… (FDA) inspection conducted between May 15 and May 19, 2023. During the inspection, an FDA investigator met with … states that internet connections were poor due to the COVID-19 pandemic. As a result, raters entered the assessment … all affected visits occurred prior to the beginning of the COVID-19 pandemic; and (3) values that were not recorded at …
EUCYT Laboratories LLC - 607182 - 06/04/2020
… or prevention of patients’ Coronavirus Disease 2019 (COVID-19). 3 Your https://eucyt.com/products/covixo/ website states … by the virus has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, the Department of Health and …
Re-Gen Active Lab, Inc. - 620763 - 05/27/2022
… Walnut Hill Lane, Irving, TX 75038, conducted between July 19, 2021 and July 28, 2021, the United States Food and Drug … manufacturing your products in October 2020 due to the COVID-19 pandemic. However, you have distributed your product after …
Namita A. Goyal, M.D. - 677324 - 10/10/2024
… screening visit. A letter addressed to you dated January 19, 2018, from Cedars-Sinai informed you that this subject … September 2020, in order to reduce the risk of exposure to COVID-19. In addition, during your inspection it was discovered …