FDA WARNING_LETTER - White Egret, Inc. - November 04, 2009

This FDA Warning Letter, issued November 18, 2009, to White Egret, Inc., details significant violations found during an October 27-November 4, 2009 inspection regarding their ear candle products, classified as medical devices. The devices were adulterated for lacking premarket approval (PMA) or investigational device exemption (IDE). They were also misbranded due to no 510(k) premarket notification, uncurrent establishment registration, and unlisted devices. Further misbranding included false/misleading labeling claiming safety and effectiveness (502(a)), inadequate directions for safe use (502(f)(1)), and being dangerous to health (502(j)), with reported injuries like ruptured eardrums and burns. The firm failed to comply with Medical Device Reporting (MDR) regulations (502(t)(2)), specifically lacking written procedures. Additionally, the devices were adulterated under 501(h) for non-conformity with Current Good Manufacturing Practice (CGMP) Quality System (QS) regulation (21 CFR Part 820). Specific QS deficiencies covered design control, process validation, complaint handling, MDR evaluation, management responsibility, device master/history records, training, and overall quality system establishment. FDA mandated immediate cessation of marketing and distribution. The firm's response, indicating they stopped sales, requires verification. Failure to promptly correct violations could lead to regulatory actions, including seizure and injunction. A written response detailing corrective actions, prevention, and plans for existing stock is required within 15 working days.