North American Diagnostics, LLC

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. 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”). Based on our review, your COVID-19 Test is intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-191 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. § 321(h).

Our inspection revealed that your COVID-19 test has been distributed in the United States (U.S.). without marketing approval, clearance, or authorization from FDA. 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. 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 under section 520(g) of the Act, 21 U.S.C. § 360j(g). Your 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 device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). 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).

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.2 In addition, on March 13, 2020, there was a Presidential declaration of 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 have distributed a product that is intended for use in mitigation, prevention, treatment, diagnosis, or cure COVID-19 in people. 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.

For 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://www.fda.gov/medical-devices/emergency-situations-medical-devices/coronavirus-covid-19-and-medical-devices. 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.

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. § 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. The violations observed include:

1. 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). Specifically, your firm did not establish design control procedures prior to the manufacture and distribution of your COVID-19 test.

2. Failure to develop, conduct, control, and monitor production processes to ensure the device conforms to its specifications, as required by 21 CDR 820.70. Specifically, your firm has not established production processes controls for your COVID-19 test, for any production and process changes, environmental control requirements, personnel requirements, contamination control requirements, manufacturing material requirements, or automated processes requirements.

3. Failure to adequately ensure that the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 CFR 820.75(a). Specifically, your firm has not conducted process validations for those processes that your firm cannot fully verify in the manufacture of your COVID-19 Test.

4. Failure to establish procedures for acceptance activities, as required by 21 CFR 820.80. Specifically, your firm has not established 1) receiving acceptance activities for any components used to manufacture your COVID-19 Test, 2) in-process acceptance activities for any process critical to the functionality and/or intended use of the device, 3) final acceptance activities.

5. Failure to establish procedures for corrective and preventive action, as required by 21 CFR 820.100(a). Specifically, your firm has not established procedures, instructions, or processes to identify, investigate, and correct problems that are observed and to prevent recurrence of issues.

6. Failure to establish procedures for control and distribution of finished devices, as required by 21 CFR 820.160(a). Specifically, your firm does not have procedures for control and distribution of your COVID-19 Test.

7. Failure to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). Specifically, your firm received information indicating that the reagent packed in plastic tubes with screw-on caps were leaking. it is not clear how this complaint was received, reviewed, or evaluated; your firm has not established procedures to handle complaints, you have not kept records of any complaints received or investigated or evaluated to determine whether the complaint represents an event which is required to be reported to FDA under part 803.

8. Failure to establish an organizational structure to ensure that devices are designed and produced in accordance 21 CFR part 820.20(b). Specifically, you have not established an organizational structure that defines the responsibilities and authority, resources, management representative, management review, quality planning and quality system procedures in accordance with good manufacturing practices set forth in the Quality System Regulation. Our inspection also revealed that you have failed to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. Specifically, your firm has not established procedures for timely and effective identification, communication, and evaluation of reportable events; a standardized review process for determining when an event meets reportability criteria; timely submission of MDRs to the FDA; or for compliance with the applicable documentation and recordkeeping requirements. Notably, during the inspection, your firm acknowledged that it does not have any MDR procedures. A device is deemed to be misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), if there was a failure or refusal to furnish any material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, which includes adverse event reports required under 21 CFR Part 803, respecting the device.

We reviewed your firm’s response dated July 6, 2022. In the response, your firm noted that you do not have certain “corrective action to propose” because you have “not manufactured test kits at the Holly Hill facility since July 2021,” and that you do “not plan to manufacture rapid antigen test kits in the near future.” However, as the manufacturer of those previously distributed devices your firm is still required under 21 CFR 803 to develop, maintain, and implement MDR procedures and ensure timely reporting of reportable events involving any device that you manufactured, even if you subsequently cease manufacturing or marketing the device. As such, your firm has an obligation to report adverse events.

Your firm should take prompt action to address any violations. Failure to adequately address the matters discussed in this letter may result in legal action being initiated by the FDA without further notice. These actions may include, but are not necessarily limited to, seizure, injunction, and civil money penalties.

Other federal agencies may take your compliance with the Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted. More information on processes for persons denied a CFG can be found at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/process-request-review-fdas-decision-not-issue-certain-export-certificates-devices.

Note, there are two response time frames specified. You should take immediate action to address any violations relating to your firm’s sale or distribution of the COVID-19 Test and to prevent future violations. 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/or 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 adulterate or 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 any violations. Include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation. 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.

FDA is advising consumers not to purchase or use certain products that are not in compliance with FDA requirements and are being misleadingly represented as safe and/or 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://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-2019-covid-19-products. Once you have taken actions to address the sale or distribution of your unapproved, uncleared, and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, and any appropriate actions have been confirmed by the FDA, the published list will be updated to indicate that your firm has taken such corrective actions.

Please also notify FDA in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the concerns noted in this letter, in particular with respect to MDR procedures and reporting. Include documentation of any corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If any corrections and/or corrective actions your firm plans to take will require more time, please include a timetable for implementation of those activities. If any corrections and/or corrective actions your firm plans to take cannot be completed within fifteen business days, state the reason for requiring additional time and the time within which these activities will be completed. We will communicate with you regarding your firm’s response(s) and any need to re-inspect your firm’s facility to verify that any appropriate corrections have been made and/or corrective actions have been taken.

Your firm’s response should be sent to: Melissa Michurski, Director of Compliance Branch, at oradevices2firmresponse@fda.hhs.gov. Refer to CMS # 643203 when replying. If you have any questions about the contents of this letter, please contact: Demetria Lueneburg, ORA Division Compliance Officer at demetria.lueneburg@fda.hhs.gov or 612-758-7210.

Finally, you should know that this letter is not intended to be an all-inclusive list of any violations at your firm’s facility or associated with your firm’s devices. This letter notifies you of our concerns and provides you with an opportunity to address them. If you believe that your products are not in violation of the Act, please provide us with your reasoning and any supporting information for our consideration. It is your firm’s responsibility to ensure that the products you sell are in compliance with the Act and FDA’s implementing regulations. Failure to adequately address the matters discussed in this letter may result in legal action, including without limitation, seizure, and injunction. The specific concerns noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be indicative of, or in addition to, other issues with your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any deficiencies and take prompt actions to address any violations and bring the products into compliance.