FDA WARNING_LETTER - Solar Wide Industrial Ltd.

The FDA issued a Warning Letter to Solar Wide Industrial Ltd. following a December 9, 2010, inspection in Hong Kong, identifying significant violations for their breast pumps and TENS devices. The devices were found adulterated under section 501(h) of the Act due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). Specific QS deficiencies included inadequate procedures for design change control (21 CFR 820.30(i)), design verification documentation (21 CFR 820.30(f)), formal design reviews (21 CFR 820.30(e)), complaint handling (21 CFR 820.198), and ensuring conformity of purchased products/services (21 CFR 820.50). The firm's initial response was largely deemed inadequate.

Additionally, devices were misbranded under section 502(t)(2) for failing to furnish Medical Device Reporting (MDR) information, specifically lacking written MDR procedures (21 CFR 803.17). The TENS devices (Stimplus Pro) were also found adulterated under section 501(f)(1)(B) and misbranded under section 502(o) because they were labeled for uncleared uses (e.g., smoking severance, eating disorders, stress/insomnia) without required premarket approval or notification.

Solar Wide must immediately cease promoting Stimplus Pro for uncleared uses and provide a written response within 15 working days detailing corrective actions, prevention plans, and a timetable. Failure to correct these violations may result in refusal of admission for devices, impact federal contracts, and hinder PMA approvals and Certificates to Foreign Governments.