FDA WARNING_LETTER - Wintech Medipro LLC - July 06, 2022

On November 16, 2022, the FDA issued a Warning Letter to Wintech Medipro following an inspection from June 22 to July 6, 2022. The firm manufactures Wintech Medipro ASTM Level 1, 2, and 3 Surgical Face Masks.

The FDA determined these masks are adulterated under section 501(f)(1)(B) of the Act because the firm lacks an approved premarket approval (PMA) application or investigational device exemption. The masks are considered devices due to claims like "protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate matter." They were distributed without FDA marketing approval, clearance, or authorization.

The devices are also misbranded under section 502(o) for failure to submit a 510(k) premarket notification, and under section 502(t)(2) for failing to furnish information required by 21 CFR Part 803 (Medical Device Reporting), specifically lacking written MDR procedures. Additionally, ASTM Level 2 and 3 masks are misbranded under section 502(b).

The inspection revealed adulteration under section 501(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). Violations include: 1. Failure to establish design control procedures (21 CFR