Wintech Medipro LLC

During an inspection of your firm located at 22110 Merchants Way, Suite 170, Katy, Texas, on June 22, 2022 through July 6, 2022, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a manufacturer of surgical masks distributed under the names Wintech Medipro ASTM Level 1 Medical Face Masks, Wintech Medipro ASTM Level 2 Surgical Face Masks, and Wintech Medipro ASTM Level 3 Surgical Face Masks (hereafter, collectively referred to as “Wintech Medipro Surgical Masks”). Accordingly, these masks 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).

Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. There was evidence collected during the inspection, including physical product labeling and your firm’s website product labeling, that revealed these products are devices within the meaning of the Act. For example, a review of your firm’s website (www.wintechmedipro.com; last accessed November 10, 2022), revealed the following claims:

“Wearing this product significantly reduces the risk of respiratory illnesses (i.e., influenza, COVID-19)”

“The medical face masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The high filter performance and low breathing resistance ensure maximum safety while maintaining maximum wearing comfort. Masks from this series have an average filtration efficiency of 99.67%. This is a single use, disposable device(s).”

Based on these claims, the products listed are intended for prevention of disease (e.g., “protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate matter”) and are therefore devices within the meaning of the Act.1

Our inspection revealed that the Wintech Medipro Surgical Masks devices have been distributed in the United States without marketing approval, clearance, or authorization from FDA. The devices are also misbranded under section 502(o) 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). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)] The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.

The Wintech Medipro Surgical Masks 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 respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360(i), and 21 CFR Part 803 - Medical Device Reporting.

Failure to develop, maintain, and implement written 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.

In addition, the Wintech Medipro ASTM Level 2 Surgical Mask and ASTM Level 3 Surgical Mask are misbranded under section 502(b) of the Act, 21 U.S.C. § 352(b), because of the following:

Device labels fail to contain the name and place of business of the manufacturer, packer, or distributor.

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. These violations include, but are not limited to, the following: 1. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a). Specifically, your firm has not established design control procedures, to include design plans, design inputs, design outputs, design reviews, design verification, design validation, design transfer, and design changes for the Wintech Medipro Surgical Masks. In, addition, your firm has not established a Design History File for the Wintech Medipro Surgical Masks.

2. Failure to establish procedures to validate a process whose results cannot be fully verified by subsequent inspection and test, as required by 21 CFR 820.75(a). Specifically, your firm has not validated the mask manufacturing process that is used to manufacture the Wintech Medipro Surgical Masks, to include qualifying the equipment used, to assure that the process can consistently produce devices that meet design specifications and intended use.

3. Failure to establish and maintain procedures for corrective and preventive actions, as required by 21 CFR 820.100(a). Specifically, there are no defined, documented, or implemented procedures for corrective and preventive actions including requirements for: analyzing quality data sources; investigating cause of nonconformities; identifying the actions needed to prevent occurrence or recurrence of nonconformities; verifying actions implemented are effective; implementing and documenting changes in methods and procedures; disseminating information related to quality problems to appropriate individuals; and submitting relevant information on quality problems for management review.

4. Failure to establish and maintain 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 processed in a uniform and timely manner, oral complaints are documented upon receipt, and complaints are evaluated to determine if the reported event is required to be submitted to the FDA as a Medical Device Report (MDR). For example, your firm did not document complaints, related to the Wintech Medipro Surgical Masks, received prior to October 2021, although you began distribution in August 2020. In addition, your firm has received approximately 113 complaints since October 2021 and have not reviewed and evaluated them to determine if the events meet MDR reporting criteria.

5. Failure to establish and maintain 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, related to the Wintech Medipro Surgical Masks, is identified, documented, evaluated, segregated, and dispositioned. For example, approximately 50 cartons of unidentified and undocumented product were observed in the warehouse area, in front of one of your firm’s three dock doors, were not identified, however, your President stated that these devices were nonconforming product. In addition, no records were maintained to demonstrate that the devices had been evaluated to determine if an investigation was needed, and devices were dispositioned.

6. Failure to establish and maintain procedures for acceptance activities, such as inspections, tests, or other verification activities, as required by 21 CFR 820.80(a). Specifically, your firm distributed Wintech Medipro Surgical Masks 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.

7. Failure to establish and maintain 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 to ensure that all purchased or otherwise received product and services, related to the Wintech Medipro Surgical Masks, conform to specified requirements. Additionally, no purchasing control procedures were established to evaluate, select, and monitor suppliers.

8. Failure to establish procedures for quality audits and to conduct such audits as required by 21 CFR 820.22. Specifically, your firm has not defined, documented, or implemented any procedures for conducting quality audits, to assure compliance with the established quality system requirements and to determine the effectiveness of the quality system. Quality Audits have not been conducted since your firm began to distribute the Wintech Medipro Surgical Masks in August 2020.

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

Other federal agencies may take your compliance with the FD&C 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.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.

Your firm’s response should be sent to: Jessica Mu, Director of Compliance Branch, at ORADevices3FirmResponse@fda.hhs.gov. Refer to CMS #640048 when replying. If you have any questions about the contents of this letter, please contact: Shaquenta Y. Perkins, Compliance Officer at (619) 941-3763 or shaquenta.perkins@fda.hhs.gov.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.