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Talk to a SpecialistTalk to a SpecialistNatuzen Co., Ltd., a South Korean manufacturer of over-the-counter drug products including Atoren Hand Sanitizer, violated Current Good Manufacturing Practice (CGMP) regulations, rendering their products adulterated. The company failed to conduct required identity testing of drug components, specifically failing to test their ethanol active ingredient for methanol contamination, citing a Korean regulatory notification as justification rather than performing independent verification. This testing gap meant the firm lacked scientific evidence that raw materials conformed to appropriate specifications before use in manufacturing. The warning was issued following FDA's review of records submitted in response to multiple requests dating back to March 2022.