![]() Specifically, your firm did not establish design control procedures prior to the manufacture and distribution of your COVID-19 test.Ģ. Failure to establish and maintain design control procedures in order to ensure that specified design requirements of the device are met, as required by 21 CFR 820.30(a). § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. This inspection also revealed that your COVID-19 test is adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. ![]() In addition, the guidance titled “ Policy for Coronavirus Disease 2019 Tests During the Public Health Emergency (Revised)” provides FDA’s review priorities and enforcement policies regarding novel coronavirus (COVID-19) tests. We request that you take immediate action to prevent distribution of such unapproved, uncleared, and unauthorized products for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.įor 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. As described herein, you have distributed a product that is intended for use in mitigation, prevention, treatment, diagnosis, or cure COVID-19 in people. 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. 2 In addition, on March 13, 2020, there was a Presidential declaration of a national emergency in response to 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. The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID-19). 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 introduction or delivery for introduction of this product into interstate commerce is prohibited under section 301(a) of the Act, 21 U.S.C §331(a). ![]() § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. Your product is also misbranded under section 502(o) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) 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. Accordingly, your product is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. Indeed, in your response dated July 6, 2022, concerning our investigators’ observations noted on the Form FDA 483 List of Inspectional Observations, that was issued to your firm, you acknowledged that you had “improperly distributed into commerce” COVID-19 test kits. without marketing approval, clearance, or authorization from FDA. ![]() Our inspection revealed that your COVID-19 test has been distributed in the United States (U.S.). Based on our review, your COVID-19 Test is intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19 1 in people, and thus, it is a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. During this inspection, FDA investigators determined that your firm is a manufacturer and distributor of SARS-CoV-2 antigen rapid test kits under the names ORAL RAPID SARS-CoV-2 Antigen Rapid test kits, SDI LABS SARS-CoV-2 Antigen Rapid Test Kit, North American Diagnostics SARS-CoV-2 Antigen Rapid Test Kit, Skippack Medical Labs SARS-CoV-2 Antigen Rapid Test (Colloidal Gold), and Spectrum DX Lab SARS-CoV-2 Antigen Rapid test kits (hereafter referred to as “COVID-19 Test”). The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations, North American Diagnostics, LLC (“North American,” “you,” or “your firm”), located at 618 Ridgewood Ave, Suite 100, Holly Hill, Florida on five dates from June 14 through 23, 2022. Issuing Office: Center for Devices and Radiological Health
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