FDA WARNING_LETTER - RoyalVibe Health Ltd. - July 05, 2022

The FDA issued a Warning Letter to Dr. Venter following an attempted inspection from June 17 to July 5, 2022, at their Woodlands, TX facility. The firm markets and distributes several products, including the CellQuicken Analyzer, RoyalVibe Ultrasound Generator, and Envirovibe Water Restructuring Pad, which the FDA determined are unapproved and uncleared medical devices under section 201(h) of the Act, based on claims for diagnosing and treating serious diseases like cancer, Alzheimer's, and diabetes. The firm's response to cease sales of RoyalVibe products was deemed insufficient as websites and apps remain active, and previously distributed adulterated devices were not addressed. The devices are adulterated under 21 U.S.C. § 351(f)(1)(B) for lacking premarket approval or investigational device exemption, and misbranded under 21 U.S.C. § 352(o) for failing to submit premarket notifications (510(k)). Additionally, the firm failed to fulfill annual establishment registration and device listing requirements for fiscal year 2022, leading to further misbranding. The FDA also cited the firm for denying and limiting inspection of its establishment under 21 U.S.C. § 351(j). The firm must provide a comprehensive plan within fifteen business days to address all violations, including a plan for previously distributed products and removal from the U.S. market, with potential regulatory actions like seizure or injunction for non-compliance.