FDA WARNING_LETTER - Care Tech Industries, Inc. - July 25, 2007

An FDA inspection of Care Tech Industries, Inc. from July 23-25, 2007, identified significant violations concerning their Odatus recirculating air cleaners. The FDA classified these products as Class II medical devices under section 201(h) of the Act due to promotional claims for treating/preventing diseases like Ebola, Asthma, and Cancer on their website and product labeling. Despite the firm's July 30, 2007, response promising removal of these claims, they remained active as of December 19, 2007, and printed materials were not addressed. The devices are misbranded under section 502(o) for lacking 510(k) clearance and adulterated under section 501(f)(1)(B) for not having an approved PMA or IDE, despite prior FDA warnings. The firm also continued to market these unapproved devices, including a "FACTORY LIQUIDATION SPECIAL," after claiming discontinuation. Further, the devices are misbranded under section 502(j) because they generate ozone (up to 0.2 ppm) exceeding the maximum acceptable concentration of 0.05 ppm (21 CFR 801.415(c)(1)). The firm is also misbranded under section 502(o) for operating an unregistered establishment and failing to list its devices, despite informing FDA of cessation of device manufacturing. Additionally, the devices are adulterated under section 501(h) due to non-compliance with eight Quality System (21 CFR Part 820) requirements, including failures in design validation, finished device acceptance, purchasing controls, complaint handling, complaint investigation, quality audits, design control, and CAPA procedures. Finally, the firm is misbranded under section 502(t)(2) for failing to establish written Medical Device Reporting (MDR) procedures (21 CFR Part 803). The firm's response was deemed inadequate for not outlining corrective actions for Quality System and MDR deficiencies. Care Tech Industries must promptly correct all violations, provide a written response within 15 working days detailing corrective actions and a timeline, or face potential regulatory actions like seizure, injunction, or civil penalties.