FDA WARNING_LETTER - Mayfair Medical Supplies Ltd - May 15, 2014

An FDA inspection of Mayfair Medical Supplies Ltd in Kowloon, Hong Kong, from May 12-15, 2014, revealed that its therapeutic infrared heating lamps, neuromuscular stimulators, and single-use acupuncture needles are adulterated and misbranded. The devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) for failing to comply with Medical Device Reporting (MDR) requirements (21 CFR Part 803).

Significant QS violations include failures to establish and maintain adequate procedures for complaint handling (21 CFR 820.198), acceptance activities (21 CFR 820.80(a)), corrective and preventive actions (21 CFR 820.100(a)), design changes (21 CFR 820.30(i)), nonconforming product control (21 CFR 820.90), purchasing controls (21 CFR 820.50), and Device Master Records (21 CFR 820.181). Additionally, the firm failed to adequately develop, maintain, and implement written MDR procedures (21 CFR 803.17), lacking systems for timely identification, evaluation, transmission, and documentation of reportable events.

The firm's responses were deemed inadequate, often failing to include necessary retrospective reviews or address systemic issues. Mayfair Medical Supplies Ltd must provide a written response within fifteen business days detailing specific, systemic corrective actions, a prevention plan, and a timetable. Failure to correct these violations may impact premarket approval applications for Class III devices and could be shared with other federal agencies.