- Delivery Method:
- VIA Electronic Mail
- Medical Devices
Recipient NameRick J. Hennessey
- Empowered Diagnostics LLC
3341 W. McNab Rd
Pompano Beach, FL 33069
- Issuing Office:
- Center for Devices and Radiological Health
October 6, 2022
Dear Mr. Hennessey:
During an inspection of your firm located at 3341 W. McNab Rd., Pompano Beach, Florida on February 3 through February 25, 2022, investigators from the United States Food and Drug Administration (FDA) determined that your firm is a medical device manufacturer and distributor of the CovClear COVID-19 Rapid Antigen Tests and the ImmunoPass COVID-19 Neutralizing Antibody Rapid Tests (hereinafter collectively referred to as “COVID-19 Test Kits”). 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, 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 these COVID-19 Test Kits have been distributed in the U.S. without marketing approval, clearance, or authorization from FDA. Accordingly, the 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 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 ImmunoPass COVID-19 Neutralizing Antibody Rapid Tests and certain configurations of your CovClear COVID-19 Rapid Antigen Tests 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 these 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.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)”4 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 devices 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, 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 are cited below.
We received your responses dated March 18, 2022; April 8, 2022; April 15, 2022; and April 29, 2022, concerning our investigator(s) observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm on February 28, 2022. We address your responses below.
Your response dated March 18, 2022, indicated that you are a small start-up seeking to market and distribute COVID-19 devices under Emergency Use Authorization in the United States. Your response references the FDA guidance document, “Emergency Use Authorization of Medical Products and Related Authorities, Guidance for Industry and other Stakeholders” issued January 2017 and that FDA may waive cGMPs on a case-by-case basis, and your response goes on to list some examples for products similar to your COVID-19 testing products. The guidance document that you have referenced also states “FDA generally expects that EUA products will be produced, stored, and distributed in compliance with CGMPs; however, limits or waivers may be granted in an EUA on a case-by-case basis, after consideration of the circumstances and of any alternative proposed approach.” However, as the devices which were distributed have not been granted EUA authorization, no such waiver of cGMPs has been granted to your firm.
The violations include, but are not limited to, the following:
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 distribution of the CovClear COVID-19 Rapid Antigen Tests. For example, Design validation activities and/or their documentation for the release of the CovClear Rapid Antigen Test were inadequate. The IFU document COVCLEAR SARS-COV-2 RAPID ANTIGEN TEST, LIT 900-027 REV 1, (not dated), states in the DIRECT TEST SWAB PROCEDURE section (p. 4) to “read results within 3-20 minutes.” All the CovClear design verification and validation documentation reviewed revealed the time for reading the test results at 20 minutes.
You must establish and maintain procedures to ensure that specified design requirements are met, this would include validating the device design to include reading results for the specified timeframe. If a user reads the results prior to the validated time, an incorrect diagnosis may result. Your design controls should ensure that the device’s specifications meet the intended use. Your response indicates that you have developed design control procedures that are compliant with the regulation. A follow-up inspection will be necessary to evaluate the effectiveness of your corrective actions.
2. Failure to adequately establish and implement corrective and preventive action procedures, as required by 21 CFR 820.100(a).
Specifically, during review of your corrective action activities, your firm indicated that an internal audit / gap analysis was conducted by a third-party auditor from May 20-24, 2021 that revealed major nonconformances to your quality system. Your Quality Department indicated that no systematic investigation to identify root causes of these reported issues or to identify similar quality issues was conducted; no corrective action plan was defined to systematically address the root causes; and no effectiveness verifications were conducted to address the deficiencies identified by the third-party auditor.
Your response indicates that you have developed procedures that are to be compliant with the regulation and have conducted training. A follow-up inspection will be necessary to evaluate the effectiveness of your corrective actions.
3. 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 procedure QP 822, CUSTOMER FEEDBACK AND COMPLAINT HANDLING, Revision A, Effective June 22, 2020 until June 29, 2021 (Revision B) was inadequate in that the procedure did not include the requirement for complaints to be evaluated to determine whether the complaint is reportable. Additionally, a review of your complaint handling activities revealed that the contact phone number provided in your IFUs was directed to a commercial phone answering system monitored by the Marketing Department. There was no documentation of any follow-up with callers to determine if the inquiries constituted complaints. There were two notification transcriptions dated October 7, 2021 and October 14, 2021 that appeared to require further investigation and were not forwarded to QA for investigation or evaluation of reportability.
We acknowledge you have revised your procedure and have conducted training. A follow-up inspection will need to be conducted to evaluate the implementation and the effectiveness of your corrective actions.
4. Failure to adequately establish procedures for finished device acceptance, as required by 21 CFR 820.80(d).
Specifically, Manufacturing Batch Record, MBR 900-005, Final QC Testing for Antigen Test which covers production lot number 02-365-03, lot size 1,270 kits/ 50 test strips with expiration dates of February 14, 2021 and June 2022 did not demonstrate the lot met the acceptance criteria for release, and this lot was distributed to customers in the United States.
Your response indicates you have identified the root cause to be inadequate procedures lacking clearly defined acceptance criteria in the final QC testing MBR. You indicate you have updated the procedures, forms, and acceptance criteria, and have conducted training. Lot 02-365-03 was subject of the recall and product destruction will be documented within a CAPA. FDA witnessed the destruction on June 30, 2022. The implementation and effectiveness of your corrective actions will be reviewed during your follow-up inspection.
5. Failure to adequately 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, you did not ensure that your suppliers perform contracted processes that impact CovClear’s performance and effectiveness in a manner that guarantees your quality specifications are consistently met.
A. The packaging process for the CovClear Rapid Antigen Test’s individually foil-wrapped configuration performed by your contract packager was not adequately validated to ensure that finished product will meet performance specifications during transportation, storage and use.
B. Your firm indicated the Machinery Acceptance Declaration, approved August 5, 2021, used by your contract packager as the validation documentation, does not include any operating parameters, processing limits, component / raw material (foil) identification, nor does it demonstrate the validation accounted for potential process variations introduced by differences in operators or packaging material lots, or how the documentation applies to the CovClear packaging.
Your response indicates that you have retained new regulatory and legal advisors and that you have developed purchasing control procedures that are compliant with the regulation. A follow-up inspection will verify the effectiveness of your corrective actions.
6. Failure to adequately establish and maintain document control procedures, as required by 21 CFR 820.40.
Specifically, your IFU document COVCLEAR SARS-COV-2 RAPID ANTIGEN TEST, LIT 900-027 REV 1, (not dated), and your marketing materials were observed to: lack the approval signature and date, the review for adequacy, and the change control within the quality system; and contain incorrect authorization status and or intended use for the CovClear Rapid Antigen Test.
Your response indicates that you have identified the root cause and have taken corrective actions including: personnel changes and conducting a recall. You indicate that you are in compliance with the regulations. A follow-up inspection is necessary to determine the effectiveness or your corrective actions.
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 federal 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 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 of the 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 of these 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/fraudulentcoronavirus-disease-2019-covid-19-products. Once you have taken actions to address the 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 related to Quality Systems. 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 will occur over time, please include a timetable for implementation of those activities. If 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 via email to: Melissa Michurski, Director of Compliance Branch, at firstname.lastname@example.org. Refer to CMS # 638164 when replying.
If you have any questions about the contents of this letter, please contact: Demetria Lueneburg, ORA Division Compliance Officer at email@example.com or 612-758-7210.
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 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.
Timothy T. Stenzel, M.D., Ph.D.
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Blake Bevill, M.S.
Program Division Director
Office of Medical Devices and Radiological Health
Division 2 Central
1 As explained below, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).
2 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.
3 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/.
4 Accessible at https://www.fda.gov/media/135659/download