UNILAM CO., LTD – FDA Warning Letter, May 22, 2026

Unilam Co., LTD, a South Korean manufacturer, received an FDA warning letter following an inspection conducted from May 18 to May 22, 2026. The agency identified significant quality system and safety violations regarding the firm"s SUV 600-800/KT/GYU UV Sunlamps. The FDA determined that Unilam"s manufacturing processes fail to meet the requirements of the Federal Food, Drug, and Cosmetic Act and the Quality System regulation (21 CFR Part 820). Key issues include a failure to implement adequate risk management, specifically regarding design controls and foreseeable risks like chemical exposure from lamp breakage. The firm also lacked proper design validation plans and failed to provide data proving that UVC emissions remain safe throughout the product’s 800-hour lifespan. Furthermore, the inspection revealed inadequate supplier evaluations and a lack of binding agreements ensuring notification of material changes. Additionally, the sunlamps are regulated as electronic products under 21 CFR Parts 1010 and 1040.20. The FDA found that Unilam failed to comply with radiation safety standards, specifically regarding testing procedures for emission certification and product aging. The company could not provide a statistical basis for its sampling plans or technical details concerning equipment calibration. To address these violations, Unilam must submit a written response within 15 business days. This response must detail specific corrective actions, provide a timeline for future improvements, and include evidence of systemic changes to prevent recurrence. The firm must also provide comprehensive technical documentation regarding their measurement methods and product performance standards. Failure to resolve these issues may lead to further regulatory actions, such as the withholding of device approvals or import restrictions.