WARNING LETTER
USA Medical LLC
MARCS-CMS 631500 —
August 03, 2022
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Damon H. Roberts
Recipient Title
President/Owner
USA Medical LLC
1220 Texan Trail, Suite 205
Grapevine
,
TX
76051-4164
United States
damon@USAMedicalllc.com
Issuing Office:
Center for Devices and Radiological Health
United States
WARNING LETTER
CMS # 631500
August 3, 2022
Dear Mr. Roberts:
The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations at USA Medical LLC (USA Medical), located at 1220 Texan Trail, Suite 205, Grapevine, TX from February 28 through March 15, 2022. During the inspection, FDA investigators determined that your firm is a medical device manufacturer and distributor of SARS-CoV-2 Antigen Rapid Test kits distributed under the names SARS-COV-2 Antigen Rapid Test,
(b)(4)
COVID-19 Ag Rapid Test
1
(hereafter, collectively referred to as “COVID-19 Tests”). Based on our review, your COVID-19 Tests are intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19
2
in people, and thus, are devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. § 321(h).
Our inspection revealed that the COVID-19 Tests have been distributed in the United States without marketing approval, clearance, or authorization from FDA. Accordingly, these products are adulterated within the meaning of section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or approved applications for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). These 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 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 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.
Your products are also misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because labeling distributed with these products included statements that the products are authorized for use under an Emergency Use Authorization (EUA). These statements create a false impression that your products have been approved or authorized for emergency use by FDA and are misleading. As discussed above, none of your COVID-19 Test Kits have been approved, cleared, or authorized for emergency use by FDA.
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, there was a Presidential declaration of 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 have distributed products that are intended for use in mitigation, prevention, treatment, diagnosis, or cure COVID-19 in people. We request that you take immediate action to prevent the 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)”
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.
Our inspection also revealed that these COVID-19 Tests are 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, in 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. We note that you have not responded to the Form FDA 483, List of Inspectional Observations issued to your firm initially on March 15, 2022, and, again in annotated form, on March 17, 2022. These violations include, but are not limited to, the following:
1. Failure to establish procedures for acceptance activities, as required by 21 CFR § 820.80(a).
Specifically, your firm distributed at least
(b)(4)
SARS-CoV-2 Antigen Rapid Test kits from 9/30/2021 – 2/24/2022 without establishing procedures for incoming product and finished device acceptance activities to ensure the device(s) conform to specified requirements and meet acceptance criteria, and acceptance records are maintained.
2. Failure to establish procedures to control product that does not conform to specified requirements, as required by 21 CFR § 820.90(a).
Specifically, your firm has not established procedures to ensure that nonconforming product is identified, documented, evaluated, segregated, and dispositioned. As you repackage and relabel tests and you do not have an authorized Emergency Use Authorization for those products, you do not have procedures regarding these nonconforming products.
3. Failure to establish procedures for control and distribution of finished devices, as required by 21 CFR § 820.160(a).
Specifically, your firm has not established and maintained procedures for the control and distribution of your SARS-CoV-2 Antigen Rapid Qualitative Test system to ensure only devices approved for release are distributed, and that purchase orders are reviewed to ensure that ambiguities and errors are resolved before devices are released for distribution. You distributed more than
(b)(4)
test kits from 9/30/2021 - 2/24/2022 to customers in the United States and did not review and approve the products prior to release/distribution.
4. Failure to establish procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR § 820.50.
Specifically, your firm has not established procedures for evaluation of suppliers, including the quality requirements that must be met by suppliers, to ensure that received products and services conform to specified requirements. The firm did not evaluate the manufacturers of the SARS-CoV-2 Antigen Rapid Test kits based on their ability to meet specified requirements, including quality requirements.
5. Failure to establish procedures for corrective and preventative action, as required by 21 CFR § 820.100(a).
Specifically, your firm has not established procedures for implementing and documenting corrective and preventive action, including requirements for: 1) analyzing quality data sources; 2) investigating the cause of nonconformities; 3) identifying the actions needed to prevent occurrence or recurrence of nonconformities; 4) ensuring actions implemented are effective; 5) documenting changes in methods and procedures; 6) disseminating information related to quality problems to appropriate individuals; and 7) submitting relevant information on quality problems for management review.
6. Failure to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR § 820.198(a).
Specifically, your firm has not established procedures for complaint handling and documentation to ensure that complaints are: 1) processed in a uniform and timely manner, 2) oral complaints are documented upon receipt, 3) complaints are evaluated to determine if the reported event is required to be submitted to the FDA as a Medical Device Report.
7. Failure to establish procedures to control environmental conditions as required by 21 CFR § 820.70(c).
Specifically, your firm has not established procedures to control environmental conditions to ensure that the SARS-CoV-2 Antigen Rapid Test products (raw materials and finished devices) are stored within the required temperature range(s) and monitored to ensure that any deviations are noted and addressed. Your firm was found to be storing test kits in its loading dock and administrative areas without procedures/requirements/monitoring. The
(b)(4)
kit has defined storage requirements.
8. Failure to establish and maintain adequate procedures to ensure that mix-ups, damage, deterioration, contamination, or other adverse effects to product do not occur during handling as required by 21 CFR § 820.140.
Specifically,
(b)(4)
boxes containing
(b)(4)
Diagnostic Kit SARS-CoV-2 Antigen Rapid Test kits (no batch/lot number identification) of products returned on 2/16/2022 in the common administrative area were observed that had not been identified, documented, or segregated as returned product.
9. Failure to establish procedures for quality audits as required by 21 CFR § 820.22.
Specifically, your firm has not established procedures for quality audits to ensure that the quality system complies with the quality system requirements and to determine the effectiveness of the quality system. Quality audits have not been performed since the firm began to distribute SARS-CoV-2 Antigen Rapid Test kits in approximately March 2020.
10. Failure to establish procedures for management review as required by 21 CFR § 820.20(c).
Specifically, your firm has not established procedures for management review of the suitability and effectiveness of the quality system. Management reviews have not been conducted since the firm began to distribute SARS-CoV-2 Antigen Rapid Test kits in approximately March 2020.
11. Failure to establish procedures for training and identifying training needs as required by 21 CFR § 820.25(b).
Specifically, your firm has not established training procedures to identify training needs and to ensure that all personnel are trained to adequately perform their responsibilities. Training records are not maintained.
12. Failure to establish a policy, and objectives for, and commitment to, quality as required by 21 CFR § 820.20(a).
Specifically, your Management with executive responsibility has not established it policy and objectives for, and commitment to, quality.
Our inspection also revealed that your COVID-19 Tests are misbranded under Section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information regarding the device that is required by or under Section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 – Medical Device Reporting.
Failure 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.
Your firm should take prompt action to address any violations. Other federal agencies may take your compliance history into account when considering the award of contracts. 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 corrected. Should FDA determine that your devices 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-requestreview-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 Kits 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 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 related to Quality Systems and MDR 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.
This response should be sent to: US Food and Drug Administration, Division 3/West, Office of Medical Device and Radiological Health Operations at oradevices3firmresponse@fda.hhs.gov. Please identify your response with CMS Case # 631500.
If you have questions about the contents of this letter, please contact Compliance Officer Raymond W. Brullo at 949-608-2918, or via email at raymond.brullo@fda.hhs.gov
Finally, you should know that this letter is not intended to be an all-inclusive list of any deficiencies 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 correct any violations and bring your products into compliance.
Sincerely,
/S/
Timothy T. Stenzel, M.D., Ph.D. Director
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
/S/
Shari J. Shambaugh
Program Division Director
Office of Medical Device and Radiological Health
Division 3
Office of Regulatory Affairs
___________________________
1
The “
(b)(4)
COVID‐19 Ag Rapid Test” distributed by your firm appears to be the
(b)(4)
COVID‐19 Ag Rapid Test manufactured by
(b)(4)
. On
(b)(4)
, 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
(b)(4)
COVID‐19 Ag Rapid Test. The test is indicated for use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, that meet the requirements to perform high complexity, moderate complexity, or waived tests and in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. However, the EUA does not authorize the distribution of the
(b)(4)
COVID‐19 Rapid Test for use outside of these specified settings.
2
As explained below, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID‐19).
3
Secretary of Health and Human Services, Determination that a Public Health Emergency Exists (originally issued Jan. 31, 2020, and subsequently renewed), available at
https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx
.
4
Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID‐19) Outbreak (Mar. 13, 2020), available at
https://trumpwhitehouse.archives.gov/presidential‐actions/proclamation‐declaring‐national‐ emergency-concerning‐novel‐coronavirus‐disease‐covid‐19‐outbreak/
.
5
Accessible at
https://www.fda.gov/media/135659/download
.
Content current as of:
08/30/2022
Regulated Product(s)
Medical Devices