FDA WARNING_LETTER - Solar Wide Industrial Ltd - December 08, 2010

On December 6-8, 2010, an FDA inspection of Solar Wide Industrial Ltd. in Shenzhen, China, revealed significant violations regarding their breast pumps and TENS devices. The Stimplus Pro TENS device, cleared for chronic and acute pain relief, was found to be labeled for uncleared uses including smoking severance, eating disorders, stress, insomnia, and "clinically tested as biologically active." This renders the devices adulterated under section 501(f)(1)(B) of the Act for lacking premarket approval (PMA) or investigational device exemption (IDE), and misbranded under section 502(o) for failure to notify the FDA of new intended uses via a 510(k) submission.

Additionally, Solar Wide failed to fulfill annual establishment registration and device listing requirements for fiscal year 2011, making all their devices misbranded under section 502(o). This non-compliance subjects their TENS devices to refusal of admission into the U.S. under section 801(a) of the Act.

The inspection also identified adulteration under section 501(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) Good Manufacturing Practice (CGMP) requirements. Specific violations included: 1. Failure to establish and maintain adequate CAPA procedures for verification and validation (21 CFR