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WARNING LETTER
CMS # 629146

June 30, 2022

Dear Dr. Wan:

The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations, W.H.P.M., Inc., located at 5358 Irwindale Ave., Suite B, Irwindale, CA on February 7 through February 28, 2022. During this inspection, FDA investigators determined that your firm is a medical device manufacturer and initial distributor/importer of the First Sign SARS-CoV-2 Antigen Test Kits, First Sign COVID-19 Surveillance Test kit, First Sign SARS-CoV-2 Antigen Test Packs (bulk products), and cobranded COVISURE SARS-CoV-2 Antigen Test Kits (hereinafter 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 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 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.

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 COVID-19 test kits are adulterated with 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 (cGMP) requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.

We received your response dated March 21, 2022, from Farokh Etemadieh, Manager of Regulatory and Quality Assurance and Dr. John Wan, CEO and President, which responded to the Form FDA 483, List of Inspectional Observations issued to your firm on February 28, 2022. We address your responses below. These violations include, but are not limited to, the following:

1. Failure to adequately establish procedures for identifying product during all stages of receipt, production, distribution, and installation, as required by 21 CFR §820.60.

Specifically, your firm has not established and maintained procedures to document the control of product label/labeling requirements and distribution of your COVID-19 Test Kits to ensure only devices approved for release and/or labeled as export only are distributed, and that manufacturing batch records are properly reviewed to ensure that ambiguities and errors are resolved before devices are released for distribution. For example:

Your firm distributed at least (b)(4) shipments of your SARS-CoV-2 Antigen Rapid Qualitative Test system by hand delivery, customer pick up, or shipped within the United States for export purposes only. Our investigators observed that your firm distributed approximately (b)(4) antigen test kits within the U.S. that are intended to be exported. There were no records to determine that the product was labeled as export only on all your COVID-19 Tests label/labeling and shipping package of the device. According to your firm, these Tests have been shipped to several customers in Texas, California, and Louisiana in September 2021 and during January and February of 2022.

We reviewed your firm’s response and conclude that the adequacy cannot be determined at this time. We acknowledge that you identified areas for improvement by developing new procedures and processes for identifying product during all stages of receipt, production, distribution, and installation. We understand that you initiated a voluntary recall of all SARS-CoV-2 Antigen Test Kits and committed to updating your export sales channel validation protocol procedures to add clarity and direction for processing product sale to customers that are not cleared or approved in the U.S. but are intended for export. In addition, your firm committed to modifying procedures to ensure identification and traceability of products, updating “FOR EXPORT ONLY” label requirements, training all personnel on the revised procedures, and conducting an investigation to determine the customers involved in the delivery of the Tests into the U.S. intended for export only. However, you did not provide evidence of implementation of your new SOPs, or evidence demonstrating that your corrective and preventative actions are effective in preventing any violations from recurring. As you stated that your actions will be completed by August 1st, 2022; and your corrective actions remain in progress, we are unable to fully assess the adequacy of your response. In response to this letter, please include updates and supporting records of your corrective actions as they progress.

2. Failure to adequately maintain quality system records, as required by 21 CFR § 820.186.

Specifically, your firm failed to maintain employee training records for your staff including your Quality Manger, Document Control Manager, Quality Assurance Coordinator, Quality Control Manger, and Inventory Control Employee. Your firm’s Employee Training Procedure, Doc. No RQS4.18.01, Version No. 4.0, Effective Date 11/23/09 requires that all WHPM personnel know the procedure to ensure they are trained, and that adequate training is conducted to certify that all personnel are competent with their job functions and regulatory requirements that affect the manufacturing operations. The manager of each department is responsible for conducting employee training and maintaining training files per your Training Plan- Matrix (IFM121). In addition, your procedure specifies that employee training records are documented on the Training Record Form (IFM013 or IFM014). However, employee Training Record Forms for the abovementioned employee roles lacked requirements such as supervisor’s signature, trainee’s name, employee’s signature, training dates, and appropriate version levels of the training.

We reviewed your firm’s response and conclude that the adequacy cannot be determined at this time. We acknowledge you have opened CAPA #22-002 to address the concerns and provided a CAPA plan to follow your procedures and improve your process for reviewing training records for completeness and accuracy to ensure that your quality system records are adequately maintained. We reviewed your retraining notices issued to all employees whose training records were identified in the inspectional observations and reviewed their employee self-training records. We understand that your Training Plan-Matrix and related training records for applicable personnel on the revised procedures were to be completed by May 2022. You did not provide supporting evidence of your corrections and we are unable to fully assess the adequacy of your response. In response to this letter, please include updates and supporting records of your corrective actions as they progress.

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-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 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 [email protected] 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/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 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 e-mail to: US Food and Drug Administration, Division 3/West, Office of Medical Device and Radiological Health Operations at [email protected]. Please identify your response with CMS case #629146 when replying. If you have questions regarding the content of this letter, please contact Compliance Officer, Charles J. Chacko at 214-253-4939, or via email at [email protected].

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 or, 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

Cc: Mr. Farokh Etemadieh
Manager of Regulatory and Quality Assurance
[email protected]

___________________________
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-novelcoronavirus-disease-covid-19-outbreak/.

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