Wintech Medipro LLC

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

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.

Passage 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.

Passage 3

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.

Passage 4

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.

Passage 5

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.