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  1. Warning Letters

WARNING LETTER

Fast Masks USA LLC MARCS-CMS 612088 —


Recipient:
Recipient Name
Jessica Owens
Recipient Title
CEO
Fast Masks USA LLC

1220 Texan Trail Suite 205
Grapevine, TX 76051
United States

shop@FastMasksUSA.com
Issuing Office:
Center for Devices and Radiological Health

United States


WARNING LETTER

Date: March 26, 2021

TO:
Heath Roberts, Registered Agent
Fast Masks USA, LLC
1324 White Dove Lane
Denton, TX 76210

RE: Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet addresses www.fastmasksusa.com and www.FastMedicalUSA.com, which resolves to www.fastmasksusa.com, on December 1, 2020,March 11, 2021, and March 22, 2021. The FDA has observed that your business offers for sale an “At-Home COVID-19 Test Kit,” a “COVID Test Kit (25 Tests),” and a “COVID-19 Antibodies Test Kit,” and distributes the “SKY Medical Supplies & Equipments, LLC Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 RAPID TEST DEVICE Whole Blood/Serum/Plasma” (hereinafter referred to as “SKY Antibody Test”), and the “Xiamen Wiz Biotech CO., LTD SARS-CoV-2 Antigen Rapid Test Test Device” (all hereinafter collectively referred to as “COVID-19 Test Kits”) in the United States. Based on our review, your COVID-19 Test Kits are intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-191 in people, and thus, they are devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. § 321(h).

The COVID-19 Test Kits are offered for sale directly to consumers for at-home testing or distributed in the United States without marketing approval, clearance, or authorization from FDA.2 Accordingly, your products are 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 products are 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 devices 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 these products into interstate commerce is prohibited under section 301(a) of the Act, 21 U.S.C. § 331(a). In addition, it is a prohibited act under section 301(k) of the Act, 21 U.S.C. § 331(k), to do any act with respect to a device while the device is held for sale after shipment in interstate commerce and results in the device being misbranded.

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.3 In addition, on March 13, 2020, the President declared a national emergency in response to COVID-19.4 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 sell products that are 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 unapproved, uncleared, and unauthorized products for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.

We also note that different and potentially serious public health risks are presented with specimen collection and testing in the home versus a healthcare setting. Risks may include, but are not limited to, whether a lay person has the ability to collect their specimen, run the test, and interpret the test result accurately. Your websites (noted above) include statements indicating that the At-Home COVID-19 Test Kit, COVID Test Kit (25 Tests), and COVID-19 Antibodies Test Kit may be purchased directly by consumers for at-home testing for COVID-19, including:

􀁸 “Our COVID Test Kits & Products
All of our products are certified and held to the highest standards possible. Our goal is to provide a fast, safe, and reliable method to test yourself in the privacy of your own home.”
[https://fastmasksusa.com]

􀁸 A picture of the At-Home COVID-19 Test Kit is accompanied by the statements:
“At-Home COVID-19 Test Kit
$64.99…
AT-HOME COVID-19 DIAGNOTISTC [sic] TEST KIT
o Results in 15 minutes
o Tells you if you [sic] currently positive/negative for the virus
o In the privacy of your own home
o For kids and adults
o Accuracy: 98.5%
o FDA Authorized and EUA Approved…

What are At-Home Coronavirus Test Kits? . . . It's quick and easy to administer, and anyone can order the test kit at home with just a few clicks. Our company then sends it along with the guidelines on sample collection. The patient then administers the test in their own home, by themselves. The patient gets results within 15-20 minutes after the test is performed. No lab is needed to obtain the results, all of this is done by the patient in the privacy of their own home.”
[https://fastmasksusa.com/at-home-covid-19-diagnostic-test-kit/]

􀁸 A picture of the COVID Test Kit is accompanied by the statements:
“COVID Test Kit (25 tests)
$495.99…
FDA APPROVED COVID-19 DIAGNOSTIC TEST KITS
o Results in 15 minutes
o In the privacy of your own home!
o For kids and adults
o Accuracy: 99.1%
o FDA Authorized & EU Approved
o 25 Test Kit box”
[https://fastmasksusa.com/covid-antibody-test-kit]

􀁸 A picture of the COVID-19 Antibodies Test Kit is accompanied by the statements:
“COVID-19 Antibodies Test Kit
$54.99…
AT-HOME COVID-19 TEST KIT FOR ANTIBODIES
o Results in 15 minutes
o In the privacy of your own home!
o FDA Approved & Authorized
o Tells you if you previously had the virus via antibodies in blood
o For kids and adults
o Accuracy: 99.1%
o 1 Test Kit box”
[https://fastmasksusa.com/covid-test-kit-individual/]

The At-Home COVID-19 Test Kit, COVID Test Kit (25 Tests), and COVID-19 Antibodies Test Kit are also misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because your website represents that these products are “FDA Approved” or “FDA Authorized.” These representations create a false impression that your products have been approved or authorized for emergency use by FDA and are misleading. As discussed above, the At-Home COVID-19 Test Kit, COVID Test Kit (25 Tests), and COVID-19 Antibodies Test Kit have not been approved or authorized for emergency use by FDA.

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-medicaldevices/coronavirus-covid-19-and-medical-devices. In addition, the guidance titled “Policy for Coronavirus Disease 2019 Tests During the Public Health Emergency (Revised)”5 provides information about FDA’s policies intended to help expand testing capacity by facilitating the development and use of COVID-19 tests during the public health emergency.

You should take immediate 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/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 these violations. 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 correct any violations may result in legal action, including, without limitation, seizure and injunction.

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 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.

This 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.

Please direct any inquiries to FDA at COVID-19-Task-Force-CDRH@fda.hhs.gov.

Sincerely,
/S/
Timothy T. Stenzel, M.D., Ph.D.
Director
OHT7: Office of In Vitro Diagnostics and Radiological
    Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

CC: info@skymedical.us

Sky Medical Supplies & Equipments, LLC
11137 NW 68 Place
Parkland, FL 33076

Sky Medical Supplies & Equipments, LLC
5987 NW 102nd Ave.
Doral, FL 33178

_________________________

1 As explained below, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).

2 The “At-Home COVID-19 Test Kit” offered for sale on your website appears to be the BinaxNOW COVID-19 Ag Card manufactured by Abbott Diagnostics Scarborough, Inc. On December 16, 2020, FDA reissued an Emergency Use Authorization (EUA) pursuant to section 564 of the Act, 21 U.S.C. § 360bbb-3, to permit emergency use of Abbott Diagnostics Scarborough, Inc.’s BinaxNOW COVID-19 Ag Card by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform moderate, high, or waived complexity tests and in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. However, this EUA does not authorize the sale of the Abbott Diagnostics Scarborough, Inc. BinaxNOW Ag Card directly to consumers for at-home testing.

The “COVID Test Kit” offered for sale on your website appears to be the Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit manufactured by Biohit Healthcare (Hefei) Co. Ltd. On June 18, 2020, FDA issued an EUA pursuant to section 564 of the Act, 21 U.S.C. § 360bbb-3, to permit emergency use of Biohit Healthcare (Hefei) Co. Ltd.’s Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit by laboratories certified under CLIA to perform moderate or high complexity tests for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human serum, plasma (heparin, dipotassium EDTA, or sodium citrate), and venipuncture whole blood (heparin, dipotassium EDTA, or sodium citrate).However, this EUA does not authorize the sale of the Biohit Healthcare (Hefei) Co. Ltd. Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit directly to consumers for at-home testing.

Labeling that accompanies the SKY Antibody Test states that it is the Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 manufactured by Xiamen Wiz Biotech Co., Ltd. The Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 manufactured by Xiamen Wiz Biotech Co., Ltd. is currently listed on FDA’s “removed” serology test list, found on the FDA’s Removal Lists of Tests that Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2 webpage at https://www.fda.gov/medicaldevices/coronavirus-covid-19-and-medical-devices/removal-lists-tests-should-no-longer-be-used-andor-distributed-covid-19-faqs-testing-sars-cov-2. The “removed” serology test list includes serology tests for which an EUA request was not submitted within a reasonable period of time, serology tests where significant problems are identified that cannot be or have not been addressed in a timely manner, and serology tests for which notification was voluntarily withdrawn by the commercial manufacturer. Tests on the “removed” serology test list should not be distributed in the United States unless and until an EUA is issued for the test or the test receives marketing approval or clearance from FDA.

3 Secretary of Health and Human Services Alex M. Azar II, Determination that a Public Health Emergency Exists (originally issued Jan. 31, 2020and subsequently renewed), available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx).

4 President Donald J. Trump, Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) (Mar. 13, 2020), available at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/).

5 Accessible at https://www fda.gov/media/135659/download.

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