FDA Warning Letter with multiple Deviations to a Korean Company

On April 16, the FDA issued another Warning Letter to Korean manufacturer C&T Dream Co., Ltd. regarding their production of over-the-counter topical medicines, following similar deficiencies noted in July 2017. Key issues highlighted include:

Despite proposed corrective actions, recurring failures indicate insufficient oversight. Production for the US market may have ceased, with the company listed for import warnings by the FDA. Remediation of deficiencies is required before resuming imports, necessitating advance notification to the FDA. Further details are available in the FDA's Warning Letter.