FDA WARNING_LETTER - Lime Essentials - September 26, 2012

The FDA issued a Warning Letter to Lime Technologies regarding its CMU3 Dental Ozone Unit, which is being marketed in the U.S. without required marketing clearance or approval. The device is deemed adulterated under 21 U.S.C. § 351(f)(1)(B) due to the absence of an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE) application. Furthermore, it is misbranded under 21 U.S.C. § 352(o) because the firm failed to submit a 510(k) premarket notification. Additionally, Lime Technologies has not fulfilled its annual establishment registration and device listing requirements for fiscal year 2012, as mandated by 21 U.S.C. § 360(p). Consequently, all of the firm's devices are considered misbranded under 21 U.S.C. § 352(o) for being processed in an unregistered establishment and not included in the required device list. The FDA requires prompt corrective action, including an immediate halt to the distribution of the CMU3 Dental Ozone Unit. The firm must respond within fifteen business days detailing corrective steps, prevention plans, and a timetable for completion, or face potential regulatory actions such as seizure, injunction, and civil money penalties.